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About 801 results for "pdufa"

Two Under The Radar Biotech Decisions To Watch Next Month

August is going to be a big month in biotech, with a number of drugs up for FDA review. Here are two August PDUFAs that might fly under the radar, but that are worth watching as they roll around. BioThrax sBLA August 15. On August 15, the FDA ..., 1 day ago

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BioSpace, 1 week ago, 2 weeks ago
Renal & Urology News, 2 months ago
Bidness Etc, 2 months ago
MedPage Today, 2 months ago
GlobeNewswire, 4 months ago

Amid Trial Concerns, FDA Delays Approval Decision for Merck & Co.'s C. Diff Drug, New PDUFA Date Set

By Mark Terry , Breaking News Staff The U.S. Food and Drug Administration (FDA) , which was to make a decision on Merck ( MRK )'s pending Biologics Licensing Application (BLA) for bezlotoxumab tomorrow, has delayed a decision until ...
 BioSpace4 days ago Merck: FDA Extends Bezlotoxumab PDUFA Goal Date By Three Months  Nasdaq4 days ago BRIEF-Durect says PDUFA date for remoxy NDA of Sept 25 unchanged  Reuters UK3 weeks ago Durect says PDUFA date for remoxy NDA of Sept 25 unchanged  Reuters UK3 weeks ago

What Is a PDUFA Date?

It's in the best interest of both pharmaceutical companies and patients to bring new drugs to the market as quickly as possible, which is why the Prescription Drug User Fee Act, or PDUFA, was established. Originally passed in 1992, PDUFA authorizes ...
 FOXBusiness.com2 weeks ago

FDA OKs Opko's Rayaldee four months ahead of PDUFA date; shares up 7% premarket

The FDA approves Opko Health's (NYSE: OPK ) RAYALDEE (calcifediol) extended release capsules for the treatment of patients with secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D ...
 Seeking Alpha1 month ago Opko Health Rockets on FDA Approval of Rayaldee Four Months Ahead of PDUFA Date  BioSpace1 month ago Regeneron: A Profitable Opportunity Regardless  Seeking Alpha5 days ago OPKO Health to Host Analyst & Investor Day in New York City on June 15  Pharmacy Choice3 weeks ago

Slingshot Insights' Expert Conference Call On Lipocine

Lipocine Inc (NASDAQ: LPCN )'s LPCN-1021's PDUFA date is coming up on June 28. Given the major potential near-term catalyst, Slingshot Insights recently conducted an expert conference call with a professor, researcher and a clinical director from ...
 Benzinga.com1 month ago
Monthly Prescribing Reference

Ad Comm will review Amgen's BLA for Humira biosimilar ABP 501; PDUFA date September 25

The FDA's Arthritis Advisory Committee will review Amgen's (NASDAQ: AMGN ) Biologics License Application (BLA) seeking approval of ABP 501, its biosimilar candidate to AbbVie's (NYSE: ABBV ) Humira (adalimumab). The specific date has not been ...
 Seeking Alpha1 month ago US FDA committee recommends approval of Valeant Pharma's brodalumab to treat moderate-to-severe plaque psoriasis  PharmaBiz5 days ago FDA Panel Recommends Approval of New Psoriasis Drug but with Some Concerns  Monthly Prescribing Reference6 days ago FDA Panel Says Valeant's Psoriasis Med Should be Approved with Risk Plan  BioSpace6 days ago

U.S. FDA grants Priority Review for Nicox's AC-170 New Drug Application

FDA assigns Prescription Drug User Fee Act (PDUFA) goal date of October 18, 2016 SOPHIA ANTIPOLIS, France, June 21, 2016 (GLOBE NEWSWIRE) -- Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today announced that ...
 Yahoo! Finance1 month ago NicOx SA Transfers Commercial Operations to New Company, Gets Minority Stake  BioSpace3 weeks ago Nicox va transférer ses opérations commerciales à une nouvelle société pharmaceutique pan-européenne spécialisée dans l'ophtalmologie créée par GHO Capital  Sante Log3 weeks ago Nicox to transfer Commercial Operations to new pan-European Ophthalmic Specialty Pharmaceutical Company led by GHO Capital  Bloomberg3 weeks ago

Cempra Announces FDA Acceptance of Solithera New Drug Applications in the Treatment of Community-Acquired Bacterial Pneumonia

PDUFA Dates of December 27 and 28, 2016 CHAPEL HILL, N.C., July 05, 2016 (GLOBE NEWSWIRE) -- ( Nasdaq:CEMP ), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial ...
 BioSpace3 weeks ago

Advanced Accelerator Applications Announces FDA Priority Review for Lutathera; PDUFA Target Action Date is December 28, 2016

AAA today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) and granted Priority Review for Lutathera, a Lu-177-labeled somatostatin analogue peptide currently under development for the ...
 BioSpace4 weeks ago BRIEF-FDA Accepts Emergent BioSolutions supplemental biologics license application for large-scale manufacturing of BioThrax in Building 55  Reuters UK1 month ago FDA completes pre-approval inspection of Emergent BioSolutions anthrax vaccine manufacturing facility  Homeland Security News Wire3 weeks ago Advanced Accelerator Applications gains FDA priority review for Novartis rival  FierceBiotech4 weeks ago

PDUFA Proposal Satisfies Companies by Accelerating Drug Approvals

Trade organizations appear satisfied with the FDA's proposed goals for the next iteration of PDUFA, citing a bevy of enhancements to drug development. PhRMA and BIO — two organizations that took lead roles in the PDUFA negotiations — found ...
 FDA News3 days ago
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