< and > Most of the. Xiaflex's PDUFA date recently faced a 3-month FDA delay, caused by new information Auxilium presented for review. Avenue Therapeutics, Inc. Pdufa approval rate. PDUFA dates are deadlines for the FDA to review new drugs. 1 month Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates Benzinga. PDUFA Date 2015-FDA Calendar 1st Edition-持续更新,欢迎补充。 新药研发 快捷药讯 小木虫 论坛. FDA reform, it would seem, has to be considered in its totality, along with the price tag, or individual mandates will keep. Rilonacept is a weekly, subcutaneously-injected recombinant dimeric fusion protein that blocks interleukin-1 alpha and interlukin-1 beta signaling. sooner than 6 calendar days after FDA response time for issuing the letter granting the meeting (see Table 1 in section VI. The Company received a notification letter from the FDA on June 5, 2019, which states that the Company’s recent submission in response to an information request from the FDA constitutes a major amendment to the NDA, and therefore, the FDA is extending the goal date by three months to provide time. If a drug is selected for priority review, the FDA is allotted six months to review the drug. Among the drugs approved in the month were Merck & Co. is recalling a single lot of Freshpet Select Small Dog Bite Size Beef & Egg Recipe Dog Food citing the potential contamination with Salmonella, a bacterium, the U. Biotech stock investing is a high. In addition, the European Medicines Agency (EMA) has validated the Type II Variation submitted for XTANDI seeking to expand the current indication to the same patient population and started the review process on March 5. The FDA accepted the application for priority review on Jan. The FDA Calendar provides tradable catalysts for biotech relates stocks, including PDUFA dates, trial data releases, upcoming conferences and events, as well as future planned PR events. If you do not know it or are unsure, speak to a midwife or GP. 05, 2017 (GLOBE NEWSWIRE) — Recro Pharma, Inc. Avenue Therapeutics Inc’s (NASDAQ: ATXI) pain drug and Zosano Pharma Corp’s (NASDAQ: ZSAN) migraine patch stumbled at the FDA altar. Supernus Pharmaceuticals Inc (NASDAQ: SUPN), Alkermes Plc (NASDAQ: ALKS),. BOSTON, June 10, Jun 10, 2021 (GLOBE NEWSWIRE via COMTEX) -- - Phase 3 data presentations on long-term treatment and substantial clinical benefits of. Streamline your research and quickly compare the relative timing of competing catalysts. Pdufa report Pdufa report. View analysts' price targets for Acasti Pharma or view top. Track upcoming PDUFA dates and FDA advisory committee meetings. Working Together to Fight COVID-19. ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials. The Ultimate Calendar Bot. Greater volume of fda pdufa meetings can be used as needed for the preparation. Ontx pdufa. 16, 2020, and set a PDUFA goal date of March 17. “We are pleased with the FDA’s decision to accept for review our NDA for. The FDA has set a PDUFA target date of April 29, 2021. (NASDAQ: ATXI) announced that the FDA is still reviewing its New Drug Application (NDA) for IV tramadol and has not provided a decision regarding the NDA. The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions. The US Food and Drug Administration (FDA) on Tuesday issued immediately effective guidance explaining how the coronavirus disease (COVID-19) public health emergency is impacting the conduct of formal meetings and its review of certain user fee-funded applications. Visit our FREE SEARCH TOOL to perform advanced searches for all of the Biotechnology events posted to our database. Compiling PDUFA dates is hard. With superior support and features such as custom calendars, events, automated announcements, RSVPs and more, DisCal is the ultimate calendar bot. comThe Week Ahead In Biotech (May 9-15): Heron, Apellis FDA Decisions, Presentations and Earnings -. 10 members in the TickerNews community. If approved, VP-102 will be marketed in. PDUFA target action date extended by three months to June 25, 2020. ACADIA Pharmaceuticals Inc. The FDA grants priority review to medicines it determines have potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. 4/1/2021 - Notice: Judicial Council of California Civil Case Coordination Proceeding 5157 Kincade Fires. The FDA had accepted the NDA for priority review on Sept. com under the Investors section/IR Calendar and will be archived for 30 days. Streamline your research and quickly compare the relative timing of competing catalysts. EMERYVILLE, Calif. Regulatory Update on DRP sNDA. health regulators on Monday approved Gilead Sciences Inc's four-drug combination pill to treat HIV. ANDA and PAS Fee- The ANDA which is filed with FDA on or after October 1st, 2012 is considered for ANDA fee. XML WPBurke f:\VHLC\052412\052412. The FDA has granted both orphan drug and breakthrough therapy status for the treatment which showed positive topline results in the Phase 3 study. Likewise Bristol-Myers Squibb's world's first interferon-free and ribavirin-free combination of. Installation: For Windows NT 3. Ahead of the upcoming PDUFA date, Wedbush analyst Laura Chico believes a successful outcome is in the cards. JZP-258 represents between 1,000 and 1,500 milligrams daily reduction of sodium for patients currently treated with Xyrem,. The anticipated Prescription Drug User Fee Act (PDUFA) action date is February 1, 2021. Indication: Recurrent pericarditis. Ontx pdufa. The FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of November 16, 2019, for the completion of its review of the Twirla (AG200-15) NDA. The FDA granted the application priority review and assigned a Prescription Drug User Fee Act (PDUFA) target date of February 2, 2021. The Company received a notification letter from the FDA on June 5, 2019, which states that the Company's recent submission in response to an information request from the FDA constitutes a major amendment to the NDA, and therefore, the FDA is extending the goal date by three months to provide time. If a drug is selected for priority review, the FDA is allotted six months to review the drug. Closeout The process by which the Federal awarding agency or pass-through entity determines that all applicable administrative actions and all required work of the Federal award have been. As previously announced, the FDA accepted the BLA, granted Priority Review designation under FDA's Accelerated Approval pathway, and indicated that it is not currently planning to hold an advisory committee meeting to discuss the application. MALVERN, Pa. Located below the FDA Calendar. NMEs are drugs that contain active moieties that have never been approved by the Food and Drug Administration previously and are indicators of innovation in drug research. PDUFA Dates: (all dates expected, are subject to change) 8/28: Stribild/Quad, Gilead Sciences Inc - Four-drug combination pill to treat HIV. Szukaj: fda pdufa goal date. Event Date. Earnings Calendar; See All Sections » treatment designed to amplify the production of heat-shock proteins is under the FDA priority review with a PDUFA action date on June 17. Economic Calendar; Resources. LAUSANNE, Switzerland-- ("PDUFA") target date of May 21, 2021. approval for rucaparib as monotherapy treatment for patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer - FDA submission based on data from TRITON clinical program in advanced prostate cancer - FDA has assigned PDUFA date of May 15, 2020 Clovis Oncology, Inc. Supernus Awaits Nod For ADHD Drug. Here are the key PDUFA catalysts for the upcoming month. BJOG: An International Journal of Obstetrics and Gynaecology. The FDA accepted the amendment and assigned a PDUFA date of Aug. FDA: May 14, 2019: Lipocine Announces Tlando NDA PDUFA Action Date of November 9, 2019: May 9, 2018: Lipocine Receives Complete Response Letter for Tlando From U. The major catalyst for the company, however, is the upcoming PDUFA date for HDX-011 (Zynrelef). Usually, the stocks experience a run-up going into the scheduled FDA Approval decision/FDA Panel review events. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of pre-cirrhotic NASH. Vanguard Dividend Appreciation ETF And iShares Russell 2000 ETF Ranked. The goal date set by the FDA for announcing its decision on a company’s New Drug Application/ Biologics License Application/sBLA/sNDA after reviewing the applications is known as the PDUFA date. is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. FDA Calendar 1 FDA Calendar 2 FDA Calendar 3 FDA Calendar 4 These calendars track upcoming PDUFA drug approval dates, FDA advisory committee meetings and Phase 2/3 trial data releases. Xiaflex's PDUFA date recently faced a 3-month FDA delay, caused by new information Auxilium presented for review. The FDA extended the PDUFA action date by three months to April 27, 2021, from January 27, 2021. , a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the U. gov, search for “IND”, IND Forms and Instructions (left hand bar) Form Approved OMB No 0910-0014 Expiration Date May 31, 2009 Required with EVERY. Fda pdufa calendar Fda pdufa calendar. Rilonacept is a weekly. Here are the key PDUFA catalysts for the month of April. 20 was extended by three months. is recalling a single lot of Freshpet Select Small Dog Bite Size Beef & Egg Recipe Dog Food citing the potential contamination with Salmonella, a bacterium, the U. The FDA review machinery worked overtime in May, completing reviews of several drug applications. A regulatory event, for example a PDUFA date or Advisory Committee Meeting will be issued with an exact date by the FDA. from Iovance. Regulatory Update on DRP sNDA. The PDUFA date is sometimes referred by investors as the "FDA Approval date". June 3-4, 2021: Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement. Pdufa calendar 2020. We appreciate both the opportunity to present these results and the committee’s strong vote of confidence. They must be gathered from a variety of sources because no central authority exists. Brussels, Belgium - 28 April 2021, 7:00 CEST - UCB announced today that the U. The FDA is normally given 10 months to review new drugs. 's (NASDAQ: ACAD) Nuplazid failed to get label expansion to include the indication of dementia-related psychosis. Get the latest information on FDA Drug Approvals, FDA Calendar, FDA Events and PDUFA dates and FDA Panel Review dates are very important New FDA Approved Drugs for 2016 | CenterWatch. 14, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced that the U. On average, they expect Acasti Pharma's stock price to reach $2. CRISPR Therapeutics Announces Trials in Progress Poster Presentation at the 2021 American Society of Clinical Oncology Annual Meeting. PDUFA date under priority review August 11, 2018. Center for Drug Evaluation and Research. This typical three-month extension offsets three of the four months that would have been gained from the FDA's earlier determination to. PDUFA was originally enacted in 1992 as the Prescription Drug User Fee Act (Pub. NTLA – Intellia Therapeutics Inc. Szukaj: fda pdufa goal date. With 14201 new cases, the number of people infected with coronavirus in the U. With COVID-19 constraining FDA's ability to carry out facility inspections, the review period was extended by three months. 10, the FDA accepted the application for priority review, assigning a PDUFA goal date of Feb. BOSTON, June 10, Jun 10, 2021 (GLOBE NEWSWIRE via COMTEX) -- - Phase 3 data presentations on long-term treatment and substantial clinical benefits of. 10 members in the TickerNews community. PDUFA date under priority review August 11, 2018. It helps you play games with your friends more often with slick event creation, timezone conversions, and more - all right inside Discord. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2017 (PDUFA VI), authorizes FDA to assess and collect fees for prescription drug. Knowledge Base article title and number. This typical three-month extension offsets three of the four months that would have been gained from the FDA’s earlier determination to. Attention Biotech Investors: Mark Your Calendar For February PDUFA Dates Coming off a stellar year, when a record 53 new molecular entities were approved, 2021 has a lot to live up to. PDUFA dates are deadlines for the FDA to review new drugs. Durect Corp. Among the NME approvals was Viela Bio Inc's (NASDAQ: VIE) lead drug Uplinza, which is indicated for neuromyelitis optica spectrum disorder. VVUS - Qnexa PDUFA date: 10/28/10. NMEs are drugs that contain active moieties that have never been approved by the Food and Drug Administration previously and are indicators of innovation in drug research. The FDA is normally given 10 months to review new drugs. Year-end reviews by the Food and Drug Administration produced mostly positive outcomes, with most therapies passing the regulatory hurdle without any hiccups. Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates Following a mixed month in April, the Food and Drug Administration sets out to review another slate of drugs in May. 11 PDUFA date for SGLT-2. Food and Drug. June 3-4, 2021: Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement. ) The first ad for Tremblay's letter touted three stocks with upcoming key dates, Durata Therapeutics (DRTX), Nektar Therapeutics (NKTR), and Pozen (POZN). However, dimming the prospects, the company informed earlier this month an Adcom meeting scheduled tentatively. View analysts' price targets for Acasti Pharma or view top. Here's a look at three PDUFA dates that will kick off 2014. (continue reading for full post) New Molecular Entity (NME) NDA and Original BLA. Food and Drug Administration (FDA) has updated the PDUFA (Prescription Drug User Fee. date the Food and Drug Administration (FDA) are expected to deliver their decision whether Meeting dates may also be viewed on the. This typical three-month extension offsets three of the four months that would have been gained from the FDA’s earlier determination to. The sBLA for rilonacept was accepted for priority review by the FDA in November, with a PDUFA goal date of March 21. In addition, the European Medicines Agency (EMA) has validated the Type II Variation submitted for XTANDI seeking to expand the current indication to the same patient population and started the review process on March 5. Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates. The FDA accepted the application for priority review on Jan. 's (NASDAQ: ACAD) Nuplazid failed to get label expansion to include the indication of dementia-related psychosis. xml 06/18/2012 16:53:58 ecblount Suspend the Rules and Pass the Bill, S. Esperion has two PDUFA dates. Susan Thaul, “The Prescription Drug User Fee Act (PDUFA): History, Reauthorization in 2007, and Effect on FDA,” Congressional Research Service Report for Congress, June 27, 2008, at http. IntelliPharmaCeutics IntelliPharmaCeutics has a sBLA for Rexista, an abuse-deterrent oxycodone hydrochloride extended release tablet used to treat pain. 10, the FDA accepted the application for priority review, assigning a PDUFA goal date of Feb. Date: June 17; NPC, according to the company, is a rare, relentlessly progressive, neurodegenerative disease, with an estimated incidence of one in 100,000 live births. If a drug is selected for priority review, the FDA is allotted six months to review the drug. Eyenovia (EYEN): Q1 GAAP EPS of -$0. Revenue of $2MAs ofMarch 31, 2021, the Company’s cash balance was. The BLA submitted by Protalix, along with its development and commercialization partner Chiesi, was accepted for priority review in August 2020 and the PDUFA date was set for Jan. 08, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced that the U. On January 29, 2021, Biogen announced that the US FDA had extended the agency's review period for aducanumab, delaying the investigational treatment's Prescription Drug User Fee Act (PDUFA) action date to June 7, 2021. "(Good article) by @Benzinga Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates $IBB $BIIB $PFE https://t. BJOG: An International Journal of Obstetrics and Gynaecology. A slew of drugs, including four new molecular entities, were approved in the month of March. NDA/BLA Submissions and Resubmissions B. To access this calendar just click the link below. Prescription Drug User Fee Act (PDUFA) goal date extended by three months for further review of submission to September 25, 2021 COPENHAGEN, Denmark, June 11, 2021 (GLOBE NEWSWIRE) — Ascendis. The average analyst consensus PT is $117. The key date is April 29, 2021 - this is the Prescription Drug User Fee Act (PDUFA) date for tenapanor. The PDUFA Day 74 Letter also states the date the NDA was submitted, which is also the date the review clock begins. The originally assigned PDUFA date was September 28, 2019. (NASDAQ: CLVS) announced today that the U. Abbvie/Enanta's non-nuke interferon-free ABT-450, which just completed Phase III, allegedly helped 96% of HCV genotype 1 variant (70% of all sufferers) patients in clinical trials, and is due to file an NDA in the first quarter of 2014. NTLA – Intellia Therapeutics Inc. PDUFA Dates: (all dates expected, are subject to change) 8/28: Stribild/Quad, Gilead Sciences Inc - Four-drug combination pill to treat HIV. Usually, the stocks experience a run-up going into the scheduled FDA Approval decision/FDA Panel review events. If a drug is selected for priority review, the FDA is allotted six months to review the drug. Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates Following a mixed month in April, the Food and Drug Administration sets out to review another slate of drugs in May. The regulatory application was filed based on results from the CheckMate -577 trial. gov, search for “IND”, IND Forms and Instructions (left hand bar) Form Approved OMB No 0910-0014 Expiration Date May 31, 2009 Required with EVERY. Food and Drug Administration's approval machinery churned out a lot of disappointments in November. 20%) VBI Vaccines announced…. On average, they expect Acasti Pharma's stock price to reach $2. *** If the scheduled date of a Type C meeting is earlier than 75 days from FDA receipt of the meeting request, the meeting package will be due no sooner than 7 calendar days after FDA response time for. Pdufa report Pdufa report. (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 31, 2021 for the review of the KYZATREX® New Drug Application (NDA) for primary. Drug Status. PDUFA Calendar; Biotech IPO Calendar; Historical Catalyst Calendar; Companies. increased to 34,264,727. The best calendar bot for Discord. PDUFA authorizes FDA to collect user fees for the process for the review of human drugs. 21 beats by $0. Avenue Therapeutics, Inc. Fda pdufa calendar. Food and Drug Administration (FDA) has set the Prescription Drug User Fee Act (PDUFA) date for UCB's Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis at October 15, 2021. Adamas undertakes no obligation to update any forward. The goal date set by the FDA for announcing its decision on a company's New Drug Application/ Biologics License Application/sBLA/sNDA after reviewing the applications is known as the PDUFA date. 11 PDUFA date for SGLT-2. PDUFA Calendar; Biotech IPO Calendar; Historical Catalyst Calendar; Companies. Avenue Therapeutics Inc’s (NASDAQ: ATXI) pain drug and Zosano Pharma Corp’s (NASDAQ: ZSAN) migraine patch stumbled at the FDA altar. Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers all companies facing upcoming PDUFA dates. Columbia Laboratories, CBRX has a PDUFA date of February 26th. --Verrica Pharmaceuticals Inc. Usually, the stocks experience a run-up going into the scheduled FDA Approval decision/FDA Panel review events. Pdufa report Pdufa report. Their forecasts range from $0. PDUFA PDUFA date June 29, 2021. 14, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. The FDA extended the PDUFA action date to allow time to review additional data submitted by Incyte in. Biotech stock investing is a high. In addition, the Company today announced that it is updating and extending its cash runway guidance. The FDA is normally given 10 months to review new drugs. The new PDUFA goal date is September 10, 2019. " This draft guidance replaces the previous draft guidance posted in 2015 on this topic. 14, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced that the U. Alzheimer’s disease (AD) is a fatal degenerative brain disease characterized by progressive loss of memory, cognitive skills such as language and problem-solving, and physical function. North-East Centre, Tezpur. Installation: For Windows NT 3. The good news is that PDUFA dates are public information and that there are several tools on the web that make finding them a breeze. Here, 24/7 Wall St. With COVID-19 constraining FDA's ability to carry out facility inspections, the review period was extended by three months. Avenue Therapeutics, Inc. Politics, Financial News and Stock Trends. On November 23 the company also released additional results from Xiaflex's Phase III IMPRESS (The I nvestigation for M aximal P eyronie's R eduction E fficacy and S afety S tudies) trial, presented at the 19th Annual Fall Scientific. PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2013 THROUGH 2017 I. The FDA is normally given 10 months to review new drugs. GOCOVRI (amantadine) extended release capsules is approved to treat dyskinesia in PD patients treated with levodopa-based therapy, with or without other dopaminergic medications. Calendar:http://stks. FDA approved 20-valent pneumococcal conjugate vaccine, under brand name Prevnar 20, on Jun. 4/1/2021 - Notice: Judicial Council of California Civil Case Coordination Proceeding 5157 Kincade Fires. Biogen's aducanumab. After about 20 months of treatment with tenapanor alone or in combination with low doses of sevelamer, patients exhibited a mean serum phosphorus reduction of 2. According to the draft guidance, from this point in time there will be 4 types of formal meetings with FDA staff. If a drug is selected for priority review, the FDA is given six months to review the drug. PDUFA PDUFA date June 29, 2021. 20, assigning it a PDUFA goal date of May 20. 20 was extended by three months. The analyst consensus for forecasted annual earnings growth is 56. Looks like SNY got their approval for Libtayo five days ago - 2/23 (I guess the big boys get better treatment). (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on therapeutics for hospital and other acute care settings, today announced that the U. Durect Corp. NCCS CANCER POLICY ROUNDTABLE MEETING Madison Hotel, Washington, D. Exact dates for clinical data releases are only rarely issued. London, UK. Food and Drug. PDUFA Goal Date - April 29, 2021. Read more to get the details on each one. Event Date: Jun 2021: Outcome Date: 06/08/2021: Outcome: FDA approved 20-valent pneumococcal conjugate vaccine, under brand name Prevnar 20, on Jun. ASCO in Action provides the latest news and analysis related to critical policy issues affecting the cancer community, updates on the Association for Clinical Oncology’s ongoing advocacy efforts, and opportunities for members and others in the cancer care community to take action. FDA Calendar 3. PDUFA PDUFA date June 29, 2021. Fda pdufa calendar. New molecular entity approvals totaled 44 thus far this year, compared to 41 approvals in the same period last year. (2019 and 2020 Candidate Report Dates PDF) For information on filing dates, please reference the Secretary of State's webpage. Moderator of r/TickerNews. Among the notable approvals that came through. Pdufa report Pdufa report. In response, the company submitted the requested analyses which constitute a major amendment to the New Drug Application (NDA), resulting in an extension of the PDUFA date by three months to July. Earnings report date is the date of an official announcement about a company's profitability for a specific time period. FDA Calendar/PDUFA Date and Advisory Committee - Valinv. Food and Drug Administration (FDA) has set the Prescription Drug User Fee Act (PDUFA) date for UCB's Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis at October 15, 2021. Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today. The product comes in 1 LB bags, with UPC code of 627975012939, lot code of 1421FBP0101 and sell by date of 10/30/2021. date the Food and Drug Administration (FDA) are expected to deliver their decision whether Meeting dates may also be viewed on the. Nektar Therapeutics is spinning off a new biotech company and gifting it with their late-stage pain drug NKTR-181 just three months ahead of a revised PDUFA date. These time frames begin on the date that an NDA is accepted by the FDA as complete. The month of October could at best be termed as mixed from the perspective of drug approvals. Although Upliinza will. New molecular entity approvals totaled 44 thus far this year, compared to 41 approvals in the same period last year. PDUFA stands for Prescription Drug User Fee Act. Links to your calendar. Visit our FREE SEARCH TOOL to perform advanced searches for all of the Biotechnology events posted to our database. NTLA – Intellia Therapeutics Inc. comAttention Biotech Investors: Mark Your Calendar For May PDUFA Dates - Benzinga; May. The study was designed to compare the immunogenicity. First up is bempedoic acid, a once-a. “We are pleased with the FDA’s decision to accept for review our NDA for. View analysts' price targets for Acasti Pharma or view top. SEND and SDTM are also expected to become required under Prescription Drug User Fee Act (PDUFA) V. Not for any advice Just an Idea. Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates By Shanthi Rexaline of Benzinga. 05/01/2021 11:43. The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to September 21, 2021. PDUFA Calendar; Biotech IPO Calendar; Historical Catalyst Calendar; Companies. 452 new deaths reported on Wednesday took the total COVID death toll in the country to 613,494. Press Releases & Statements. The regulatory application was filed based on results from the CheckMate -577 trial. Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates. A regulatory event, for example a PDUFA date or Advisory Committee Meeting will be issued with an exact date by the FDA. --Verrica Pharmaceuticals Inc. Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates Despite the FDA tied up with COVID-19-related activities, May turned out to be a positive month for biopharma companies from the perspective of drug approvals. 14, 2016 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. Attention Biotech Investors: Mark Your Calendar For These February PDUFA Dates by admin • 3 February, 2020 Biotech stocks have come under some selling pressure in the new year. Stock Performance after PDUFA Date and Phase III Results Released - Valinv. However, feedback from industry and details of an outside consultant's report. A slew of drugs, including four new molecular entities, were approved in the month of March. Novavax Announces Positive Data from Three Complementary Studies of COVID-19 Beta (B. 3187, with An Amendment (The amendment strikes all after the enacting clause and inserts a new text). After about 20 months of treatment with tenapanor alone or in combination with low doses of sevelamer, patients exhibited a mean serum phosphorus reduction of 2. Cash, cash equivalents, and marketable securities were approximately $35. Company: Pfizer Inc. Prescription Drug User Fee Act target action date of May 21, 2021; November 20, 2020 07:00 AM Eastern Standard Time. Form FDA 1571 Has to be current, always check www. If approved, VP-102 will be marketed in. Exact dates for clinical data releases are only rarely issued. co/fkARgz2z24 # via @benzinga”. The analyst consensus for forecasted annual earnings growth is 56. 6 days Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates Benzinga. Basel, June 2, 2020 — Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Amgen dropped co-development rights for axalimogene filolisbac in December 2018. (NYSE: BHC) has a PDUFA target action date scheduled on. The month saw the approval of five new molecular entities, which are drugs with active ingredients that have not been approved previously. The MS formula is a blend of fundamental and technical analysis made to minimize risk and maximize profits. In some situations, PDUFA fees can be waived, reduced, or refunded. (NASDAQ: ATXI) announced that the FDA is still reviewing its New Drug Application (NDA) for IV tramadol and has not provided a decision regarding the NDA. Super flexible time parsing. And we have heard time and again that the Duchenne community is recognized as leaders and innovators in the patient focused drug development (PFDD) space; a space which was created through PDUFA V. The FDA granted the application priority review and assigned a Prescription Drug User Fee Act (PDUFA) target date of February 2, 2021. Following a mixed month in April, the Food and Drug Administration sets out to review another slate of drugs in May. Among the notable approvals that came through. Eyenovia (EYEN): Q1 GAAP EPS of -$0. New molecular entity approvals totaled 44 thus far this year, compared to 41 approvals in the same period last year. The sBLA for rilonacept was accepted for priority review by the FDA in November, with a PDUFA goal date of March 21. that are filed by FDA under the Program, the PDUFA review clock will begin at the conclusion of the 60 calendar day filing review period that begins on the date of FDA receipt of the original. The Company believes the results of these analyses. comThe Week Ahead In Biotech (May 9-15): Heron, Apellis FDA Decisions, Presentations and Earnings -. 22, 2021 - seekingalpha. 11 PDUFA date for SGLT-2. health regulators on Monday approved Gilead Sciences Inc's four-drug combination pill to treat HIV. Here are the key PDUFA catalysts for the upcoming month. The PDUFA/FDA Approval Calendar and Finding Potential FDA Approval Catalyst Dates. On the PDUFA date the FDA will either: - issue approval for marketing. Aurinia pharmaceuticals has one of the most important milestones in its history in a few weeks: Next January 22, 2021 is the PDUFA where the FDA will decide the approval of the candidate drug. Web participants are encouraged to go to the website 15 minutes. xml 05/24/2012 16:04:39 ecblount x:\xx\xxxxxx\xxxxxx. DisCal is a powerful Discord bot allowing you to connect Google Calendar to Discord in a seamless fashion. Related Link: Why This Bristol-Myers Squibb Stock Analyst Is Turning Bullish On The Pharma Company's Pipeline. (1) When it allocates a case to the fast track, the court will give directions for the management of the case and set a timetable for the steps to be taken between the giving of the directions and the trial. the agency is meeting or exceeding nearly all PDUFA goals for application review. In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), which allows the US Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the drug review and approval process. In addition, the European Medicines Agency (EMA) has validated the Type II Variation submitted for XTANDI seeking to expand the current indication to the same patient population and started the review process on March 5. A Prescription Drug User Fee Act (PDUFA) goal date has been set for August 7, 2020. Upcoming Events. Installation: Fixed bug with AMD-ATI videoadapters install. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for FINTEPLA® for the treatment of seizures. Orphazyme's applications for arimoclomol for Niemann-Pick disease type C (NPC) are under priority review with the U. NMEs are a measure of innovation among biopharma companies, as they refer to drugs containing an active ingredient that has never been approved previously. 2/5 (1,620 Views. The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. 1 like • 6 shares. ACADIA Pharmaceuticals Inc. ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ ᅠ Select Download Format Fda Meeting Guidance Pdufa Download Fda Meeting Guidance Pdufa PDF Download Fda Meeting Guidance Pdufa DOC ᅠ Our tools on the fda guidance pdufa fee exemptions, and cber for the authority citation is designated product is given. Indication: Recurrent pericarditis. It is not all smooth sailing from now on for Sovaldi, however. PDUFA Goal Date - April 29, 2021. , a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the U. Exact dates for clinical data releases are only rarely issued. This presentation contains forward-looking statements. The Company received a notification letter from the FDA on June 5, 2019, which states that the Company’s recent submission in response to an information request from the FDA constitutes a major amendment to the NDA, and therefore, the FDA is extending the goal date by three months to provide time. Food and Drug Administration's approval machinery churned out a lot of disappointments in November. An acknowledgement letter from the FDA in February 2021 stated that the Company’s resubmission of its NDA for IV tramadol was a complete, class 1 response to the Complete Response Letter (“CRL”) dated October 9, 2020 and the resubmission had been assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of April 12, 2021. The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this sNDA is September 28, 2019. CRISPR Therapeutics Provides Business Update and Reports First Quarter 2021 Financial Results. PDUFA appointments are deadlines for the FDA to review new drugs. It was initially approved by the FDA in 2008 for the treatment of thrombocytopenia in adults with. If approved, VP-102 will be marketed in. Tumor recognition and lysis by TIL from Iovance on Vimeo. Original Efficacy Supplements C. the agency is meeting or exceeding nearly all PDUFA goals for application review. FDA Calendar, FDA Drug Approval, PDUFA Dates – RTTNews The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2021. PDUFA PDUFA date June 29, 2021. comHeron Therapeutics climbs on management comments on upcoming milestone - Seeking Alpha; May. New molecular entity approvals totaled five during the month. FDA, with an expected PDUFA action date of June 17, 2021. Autograft, the current standard of care for deep partial. (Nasdaq: LXRX) today announced that the U. Quizzes Baby Shower Due date calculator Weight Gain Calculator. Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates Shanthi Rexaline 5/1/2021. Also known as an FDA Action Date, June 1, 2021, is an important PDUFA date for Alkermes plc ( ALKS ), a biopharmaceutical company, as it will receive a decision from the FDA on whether or not it. Here are the key PDUFA dates for the first month of the new year. Use this pregnancy due date calculator to find out when your baby is due. So that we don't have questions and speculations EVERY time a new PDUFA action date is announced by a biotech or pharmaceutical company, here is the complete run-down of the current timelines. CYDY CytoDyn Inc (QB) The FDA Calendar Review Dates Can Play a Big Role in Timing Your Trades, But Not the Way You May Think New York, NY -- January 7, 2021 -- InvestorsHub NewsWire -- Traders News Source, a leading independent equity research and corporate access firm focused on small cap growth companies issues. Phase 1/2/3) are provided in a range format by companies (e. The product is under review with the FDA and has been assigned a PDUFA date of May 29, 2021. Esperion Therapeutics (NASDAQ:ESPR) holds the distinction of having two PDUFA dates just days apart on Feb. SEC filings are a great source of information, but they only capture about 75. The PDUFA Date for Shield Therapeutics' ferric maltol (Feraccru) is 7/27/19. June 18, 2021 at 11:00 AM EDT. The FDA has assigned a Prescription Drug User Fee Act ("PDUFA") target action date of January 5, 2022. 6%, compared to the industry average of 14. The Pharmaceutical Research and Manufacturers of America, PhRMA, represents the country’s leading biopharmaceutical researchers and biotechnology companies. Rilonacept is a weekly, subcutaneously-injected recombinant. Their forecasts range from $0. If you do not know it or are unsure, speak to a midwife or GP. gov, search for “IND”, IND Forms and Instructions (left hand bar) Form Approved OMB No 0910-0014 Expiration Date May 31, 2009 Required with EVERY. Durect Corp. PDUFA dates and FDA Panel Review dates are very important catalysts because they are ‘make or break events’ for biotech stocks. 当前位置: 首页 > 新药研发 > PDUFA Date 2015-FDA Calendar 1st Edition-持续更新,欢迎补充。 作者 紫铃风醉 来源: 小木虫 200 4 举报帖子. You need to know the first day of your last period to use this calculator. Moderator of r/TickerNews. 8 million as of December 31, 2019, which the Company believes will be sufficient to fund. Tumor recognition and lysis by TIL. PDUFA VII negotiations wind up; CMC, IT modernization issues resolved. NTLA – Intellia Therapeutics Inc. G1 Therapeutics Inc NASDAQ Updated Jun 11, 2021 11:37 PM. The PDUFA date is the target action date for the FDA to make a decision about a NDA. FDA Calendar for biotech investing. Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today. The original PDUFA date of Dec. A required review of the US Food and Drug Administration's communication with industry found that communication was overall timely, collaborative and effective at moving development programs down the road. PDUFA Date Calendar for Biotech Stocks • BioPharmCatalyst. Trial Tracker. 5651, with An Amendment (The amendment strikes all after the enacting clause and inserts a new text). And, over a decade since its clinical development started, Pfizer/Lilly’s troubled pain project tanezumab will be up for discussion. Pricing; Contact; Select Page. Intercept's Ocaliva has a tentative panel date of April 22, and any timeline update would hit the PDUFA, which is scheduled for June. Ceremonies and Observances Even. ACADIA Pharmaceuticals Inc. 18, 2021 /PRNewswire/ -- Protalix BioTherapeutics,. (Nasdaq: AGRX), a women’s healthcare company, today announced that the U. From the classroom to the boardroom, WRDS is more than just a data platform — data validation, flexible delivery options, simultaneous access to multiple data sources, and dedicated client support provided by doctoral-level professionals. PDUFA Calendar; Biotech IPO Calendar; Historical Catalyst Calendar; Companies. Update: Due to Aducanumab’s New PDUFA Date, ICER Extends Timeline for Alzheimer’s Disease Assessment. (2) When it gives directions, the court will –. The PDUFA/FDA Approval Calendar and Finding Potential FDA Approval Catalyst Dates. In some situations, PDUFA fees can be waived, reduced, or refunded. PDUFA Date Calendar for Biotech Stocks • BioPharmCatalyst. Date: March 21. Specialty Drug 2019 Prescription Drug User Fee Act (PDUFA) Schedule – FDA Calendar Posted on January 22, 2019 August 30, 2019 by Todd Cooperman Enacted in 1992, the Prescription Drug User Fee Act (PDUFA) was created to authorize the Food and Drug Administration (FDA) to collect fees from companies that produce certain human drug and biological products. Full results can be found by expanding the selection criteria. Biogen's aducanumab. This typical three-month extension offsets three of the four months that would have been gained from the FDA’s earlier determination to. The new PDUFA goal date is June 26, 2020. Author: Adam Burden Created Date: 7/2/2020 7:45:38 AM. PDUFA dates are deadlines for the FDA to review new drugs. 8, 2021: Drug Status: Rival Drugs: Pfizer's Prevnar 13, which offers protection against 13 strains of pneumococcal virus, recorded global sales of $5. Novavax to Host Maryland Governor Larry Hogan at Site of Future Novavax Vaccines Innovation Campus and Global Headquarters. Food and Drug. --Verrica Pharmaceuticals Inc. If a drug is selected for priority review, the FDA is allotted six months to review the drug. 21 beats by $0. PDUFA PDUFA date June 29, 2021. New molecular entity approvals totaled 44 thus far this year, compared to 41 approvals in the same period last year. The originally assigned PDUFA date was September 28, 2019. 27 was pushed back by three months after the company provided additional information to the FDA in response to the agency's request related to non-clinical studies. The FDA is normally given 10 months to review new drugs. Moderator of r/TickerNews. HDX-011 is indicated for use to control postoperative pain in small to medium. Fibrogen said at that time it is submitting additional analyses of existing roxadustat clinical data, which require an extension of. Xyrem is the only available product approved to treat both cataplexy and EDS in patients with narcolepsy ages 7 years and older and is the standard of care for treatment of cataplexy. BJOG: An International Journal of Obstetrics and Gynaecology. If a drug is selected for priority review, the FDA is allotted six months to review the drug. Eyenovia (EYEN): Q1 GAAP EPS of -$0. Date: June 17; NPC, according to the company, is a rare, relentlessly progressive, neurodegenerative disease, with an estimated incidence of one in 100,000 live births. BOSTON, June 10, Jun 10, 2021 (GLOBE NEWSWIRE via COMTEX) -- - Phase 3 data presentations on long-term treatment and substantial clinical benefits of. PDUFA Goal Date Extended to February 28, 2017. Autograft, the current standard of care for deep partial. Although the calendar for drug approval decisions, known as PDUFA dates, for January was fairly light, most verdicts issued in the month were positive. Dogecoin is up over 10,000% so far in 2021. With COVID-19 constraining FDA's ability to carry out facility inspections, the review period was extended by three months. Ontx pdufa. 15: Medpace Holdings Inc. Freshpet Inc. Indication: Recurrent pericarditis. Related Link: Why This Bristol-Myers Squibb Stock Analyst Is Turning Bullish On The Pharma Company's Pipeline. Keyword CPC PCC Volume Score; pdufa fda: 1. 452 new deaths reported on Wednesday took the total COVID death toll in the country to 613,494. The busy calendar of June proved positive for drug approvals, with most scheduled events producing positive outcomes. (NASDAQ: DRRX) announced in October that the FDA will be discussing its Class 2 NDA. xml 05/24/2012 16:04:39 ecblount x:\xx\xxxxxx\xxxxxx. 10, the FDA accepted the application for priority review, assigning a PDUFA goal date of Feb. 21 beats by $0. Earnings Calendar; See All Sections » treatment designed to amplify the production of heat-shock proteins is under the FDA priority review with a PDUFA action date on June 17. PDUFA dates and content are essential for portfolio managers of healthcare stocks. PRINCETON, N. MS Money Moves – Looking to join a biotech trading team? Learn what stocks we are buying and why. The Pharmaceutical Research and Manufacturers of America, PhRMA, represents the country’s leading biopharmaceutical researchers and biotechnology companies. FDA Calendar/PDUFA Date and Advisory Committee - Valinv. With superior support and features such as custom calendars, events, automated announcements, RSVPs and more, DisCal is the ultimate calendar bot. The FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of November 16, 2019, for the completion of its review of the Twirla (AG200-15) NDA. Closeout The process by which the Federal awarding agency or pass-through entity determines that all applicable administrative actions and all required work of the Federal award have been. 05/01/2021 11:43. is recalling a single lot of Freshpet Select Small Dog Bite Size Beef & Egg Recipe Dog Food citing the potential contamination with Salmonella, a bacterium, the U. 351) Variant Strain Vaccine. FDA, with an expected PDUFA action date of June 17, 2021. New molecular entity approvals totaled 44 thus far this year, compared to 41 approvals in the same period last year. Ceremonies and Observances Even. Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates. Tuesday, Feb. Attention Biotech Investors: Mark Your Calendar For February PDUFA Dates Coming off a stellar year, when a record 53 new molecular entities were approved, 2021 has a lot to live up to. These statements relate to future events and involve known and. --Verrica Pharmaceuticals Inc. require hospitalization for the. Rilonacept is a weekly, subcutaneously-injected recombinant. Ontx pdufa. Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U. Jenkins noted that the commercial IND pipeline of new drugs under development remains strong and is growing. 42 Votes) CBE 30 means a regulatory submission to the FDA at least thirty days prior to distribution of Product indicating changes being effected to the NDA 16-151 as defined in 21 CFR 314. Here are the key PDUFA dates for November. Here is the history performance of biotech stock after FDA Approved/Rejected the products or clinical trial data released. The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States. Corporate and Finance. Exact dates for clinical data releases are only rarely issued. A single positive or negative announcement from the US Food and Drug Administration (FDA) can send shares of a. Most of the negative verdicts were tied to difficulties the agency has had in inspecting facilities where investigational drugs are being manufactured, amid COVID-19-related restrictions. 3187, with An Amendment (The amendment strikes all after the enacting clause and inserts a new text). 7% from the stock's current price. PDUFA Goal Date - April 29, 2021. Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates By Benzinga - Jun 02, 2021 The FDA review machinery worked overtime in May, completing reviews of several drug applications. Symbol Product Stage Achievement Stock Performance Volume Released Date; NEOS: Cotempla XR-ODT. And over the past five years, bitcoin has experienced growth of about 14,000%. Alnylam Pharmaceuticals, Inc. the agency is meeting or exceeding nearly all PDUFA goals for application review. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of April 29, 2021. (a) fix the trial date; or. Food and Drug Administration's approval machinery churned out a lot of disappointments in November. Deemed a Class 2 resubmission by the FDA, the agency has assigned a six-month review period and a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2020. NTLA – Intellia Therapeutics Inc. This is the fifth reauthorization of the Prescription Drug User Fee Act or PDUFA, first enacted in 1992, and the third reauthorization of the Medical Device User Fee Act, or MDUFA, first enacted in 2002. PDUFA date and FDA Calendar for biotech investing. The regulatory application was filed based on results from the CheckMate -577 trial. 16, 2020, and set a PDUFA goal date of March 17. FDA Calendar. Fda pdufa calendar. Sydney and Bedminster, NJ /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the US Food and Drug Administration (FDA) has set 26 August 2013 as the Prescription Drug User Fee Act (PDUFA) date for action on the Company's resubmitted MOXDUO New Drug Application (NDA). 21 beats by $0. The FDA has set a PDUFA target date of April 29, 2021. Here are the key PDUFA catalysts for the month of April. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical. "We developed JZP-258 to be a safer and long-term treatment option for patients. 10, the FDA accepted the application for priority review, assigning a PDUFA goal date of Feb. Fda pdufa calendar Fda pdufa calendar. Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates Following a mixed month in April, the Food and Drug Administration sets out to review another slate of drugs in May. comAttention Biotech Investors: Mark Your Calendar For May PDUFA Dates - Benzinga; May. Exact dates for clinical data releases are only rarely issued. FDA Calendar, FDA Drug Approval, PDUFA Dates – RTTNews The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2021. 5 Wall Street analysts have issued 12 month price targets for Acasti Pharma's shares. The FDA granted the application priority review and assigned a Prescription Drug User Fee Act (PDUFA) target date of February 2, 2021. The templates available in this page includes 2020 public holidays for the USA. FDA calendar is a useful tool to know PDUFA dates related to FDA Approval and FDA Panel review of New Drug Applications, which are catalysts of Biotech Stocks. PDUFA appointments are deadlines for the FDA to review new drugs. T hose invested in the precision therapy company Blueprint Medicines Corp. The following four companies were listed for 2/28 CRMD. A Prescription Drug User Fee Act (PDUFA) goal date has been set for August 7, 2020. Regulatory Update on DRP sNDA. 8, 2021: Drug Status: Rival Drugs: Pfizer's Prevnar 13, which offers protection against 13 strains of pneumococcal virus, recorded global sales of $5. If fda guidance for good reason remove its pdufa date as fda pdufa bundling guidance this agreement for combination. The busy calendar of June proved positive for drug approvals, with most scheduled events producing positive outcomes. The Phase 2 trial data is expected by year's end; the PDUFA goal date for the NDA on the molluscum contagiosum trial is expected by September 23, 2021. Your health care provider will confirm the baby's gestational age with a first trimester ultrasound. The FDA accepted the application for priority review on Jan. FDA PDUFA dates and FDA Panel Review dates Economic Calendar. It is a one-time fee for each individual DMF, incurred on first reference of the DMF on or after Oct. Year-end reviews by the Food and Drug Administration produced mostly positive outcomes, with most therapies passing the regulatory hurdle without any hiccups. As Adamis has previously stated, in connection with its acceptance for review of the NDA the FDA previously provided a PDUFA target agency action date of October 31, 2019. An acknowledgement letter from the FDA in February 2021 stated that the Company's resubmission of its NDA for IV tramadol was a complete, class 1 response to the Complete Response Letter ("CRL") dated October 9, 2020 and the resubmission had been assigned a Prescription Drug User Fee Act ("PDUFA") goal date of April 12, 2021. A Prescription Drug User Fee Act (PDUFA) goal date has been set for August 7, 2020. Tumor recognition and lysis by TIL from Iovance on Vimeo. Although the calendar for drug approval decisions, known as PDUFA dates, for January was fairly light, most verdicts issued in the month were positive. Not for any advice Just an Idea. The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. PDUFA was originally enacted in 1992 as the Prescription Drug User Fee Act (Pub. Additionally, a PDUFA date is a day on which a pharmaceutical company expects a decision to be reached regarding the safety of its product. Intercept's Ocaliva has a tentative panel date of April 22, and any timeline update would hit the PDUFA, which is scheduled for June. Naegele's rule: A reappraisal. Get the latest information on FDA Drug Approvals, FDA Calendar, FDA Events and PDUFA dates and FDA Panel Review dates are very important New FDA Approved Drugs for 2016 | CenterWatch. The PDUFA date is the target action date for the FDA to make a decision about a NDA. Ontx pdufa. Prescription Drug User Fee Act (PDUFA) goal date extended by three months for further review of submission to September 25, 2021 COPENHAGEN, Denmark, June 11, 2021 (GLOBE NEWSWIRE) — Ascendis.