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About 800 results for "pdufa"

Synergy Pharmaceuticals Announces Positive Results in Second Phase 3 Trial of Plecanatide in...

What To Make Of Synergy Pharmaceuticals With Key PDUFA Date Ap...

Summary Synergy Pharmaceuticals' primary drug candidate plecanatide has its PDUFA date with the FDA in less than two weeks. Although approval chances based on trial results appear very high, the stock may not pop as much as some investors ... Seeking Alpha, 46 minutes ago
Buy Synergy Pharmaceuticals Before PDUFA Seeking Alpha, 1 week ago

33 images for pdufa, 2 days ago
Nasdaq, 3 days ago
Nasdaq, 3 days ago
Pharma Letter, 1 week ago
FierceBiotech, 4 weeks ago, 2 months ago
Medtech Insight, 2 months ago, 3 months ago, 3 months ago
BioSpace, 3 months ago

Incyte PDUFA Date Pushed Back, JMP Discusses Impact

There has been a three-month delay in the Food and Drug Administration Prescription Drug User Fee Act date for Incyte Corporation (NASDAQ: INCY )'s partnered rheumatoid arthritis drug, baricitinib. The U.S. approval and launch of the drug is now ...
 Benzinga.com2 days ago FDA extends review period by three months for Lilly and Incyte's rheumatoid arthritis candidate baricitinib  Seeking Alpha3 days ago FDA Pushes Review Date for Ocrelizumab in MS  General Medicine eJournal4 weeks ago Roche (RHHBY) MS Drug FDA Review Date Extended in U.S.  Zacks.com4 weeks ago

Lilly-Incyte Rheumatoid Arthritis Drug PDUFA Date Extended

Eli Lilly and Company LLY and partner Incyte Corporation INCY announced that the FDA has extended the time to review the company's New Drug Application (NDA) seeking approval of its pipeline candidate baricitinib for the treatment of rheumatoid ...
 Yahoo! Finance3 days ago

Adamas Pharmaceuticals Inc (ADMS) Is Up On PDUFA: What's Next?

Adamas Pharmaceuticals Inc (NASDAQ: ADMS ) is up close to 15% on its 2017 open, on the back of a couple of positive developments out of its Parkinson's disease pipeline. The company had a pretty rocky 2016, with volatile trading the order of the ...
 InsiderMonkey.com1 week ago ADAMAS PHARMACEUTICALS INC (NASDAQ : ADMS) Is Up On PDUFA: What's Next?  4 Traders1 week ago

A Preview Of January PDUFA Dates

Biopharma companies did not have much to write home about in the year 2016, as negative news flow on price gouging hit many stocks in the space. The SPDR S&P Biotech (ETF) (NYSE: XBI ) and the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB ) ...
 Benzinga.com3 weeks ago

What Happened To Cempra's PDUFA Dates?

Cempra Inc (NASDAQ: CEMP ) investors, whose shares had taken a pounding in early November, were waiting for a couple of big catalysts that could drive a rebound this week. The FDA had set two target dates to take action on solithromycin under the ...
 Benzinga.com3 weeks ago Cempra's Electric Kool-Aid Acid Test  Seeking Alpha6 days ago Is There Any Value Left In Cempra Or Solithromycin?  Seeking Alpha2 weeks ago

FDA delays Cempra antibiotic over manufacturing, safety issues

Its PDUFA dates came and went this week, and both the FDA and Cempra were ominously silent. Then Thursday morning, the Chapel Hill, North Carolina-based biotech announced what looked inevitable: a complete response letter for solithromycin. The ...
 FierceBiotech2 weeks ago What You Need To Know About Cempra's 2 PDUFA Dates This Week  Benzinga.com3 weeks ago

VERNALIS PLC : FDA accepts CCP-08 NDA for full review

FDA accepts CCP-08 NDA for full review PDUFA date of 4 August 2017 Vernalis plc and Tris Pharma, Inc. ("Tris") are pleased to announce that the U.S. Food and Drug Administration ("FDA") has accepted the CCP-08 New Drug Application ("NDA") for full ...
 4 Traders4 weeks ago Vernalis PLC: FDA accepts CCP-08 NDA for full review  Yahoo! Finance4 weeks ago FDA accepts CCP-08 NDA for full review  MoneyAM4 weeks ago Tris Pharma, Inc. Release: FDA Accepts CCP-08 NDA For Full Review  BioSpace4 weeks ago

Tesaro bags priority review, June PDUFA date for PARP inhibitor

The FDA has granted priority review status to Tesaro's PARP inhibitor niraparib. The regulatory status sets Tesaro up to secure approval for niraparib in ovarian cancer by June 30 without going through an advisory committee meeting. Tesaro ...
 FierceBiotech4 weeks ago Tesaro Announces Priority Review Designation for Niraparib NDA  Yahoo! Finance4 weeks ago

Emmaus Life Sciences Receives Notice of FDA PDUFA Date for Investigational L-glutamine Treatment for Sickle Cell Disease

By a News Reporter-Staff News Editor at Clinical Trials Week - Emmaus Life Sciences, Inc. announced that the U.S. Food and Drug Administration has set a PDUFA date of July 7, 2017 for a decision on the Company's New Drug Application for its ...
 Pharmacy Choice1 month ago Ezra Announces FDA Acceptance Of Filing Of New Drug Application For EZR-104 For The Treatment Of Hypertension And Heart Failure  Minyanville20 hours ago Ezra Release: Company Announces FDA Acceptance Of Filing Of New Drug Application For EZR-104 For The Treatment Of Hypertension And Heart Failure  BioSpace2 hours ago IRONWOOD PHARMACEUTICALS : Announces New Drug Application for DUZALLO Fixed-Dose Combination of Lesinurad and Allopurinol Has Been Accepted for FDA Review  4 Traders6 days ago
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