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About 800 results for "pdufa"

Synergy Pharmaceuticals' NDA for Plecanatide awarded US PDUFA ...

Biopharmaceutical company Synergy Pharmaceuticals (NasdaqGS:SGYP) said on Tuesday that its New Drug Application (NDA) for plecanatide for the treatment of chronic idiopathic constipation (CIC) is now sufficiently complete to permit a substantive ... Bloomberg, 1 week ago
Synergy Pharmaceuticals Inc ( SGYP ) Stock Junction, 1 week ago

BRIEF-Synergy pharmaceuticals says FDA set Jan 29, 2017 as PDUFA for constipation drug

News and Media Division of Thomson Reuters Thomson Reuters is the world's largest international multimedia news agency, providing investing news, world news, business news, technology news, headline news, small business news, news alerts, ...
 Reuters UK2 weeks ago

Valeant and Progenics reports PDUFA's new extended date of 19 July 2016 for Oral RELISTO

Pharmaceutical company Valeant Pharmaceuticals (NYSE:VRX) and Progenics Pharmaceuticals (NasdaqGS:PGNX) Monday jointly announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its ...
 Bloomberg4 weeks ago BRIEF-Progenics Pharma, Valeant say FDA extended Relistor PDUFA to July 19  Reuters UK4 weeks ago Valeant Pharmaceuticals Intl : and Progenics Announce PDUFA Date Extension for Oral RELISTOR  4 Traders4 weeks ago Valeant and Progenics Announce PDUFA Date Extension for Oral RELISTOR  Benzinga.com4 weeks ago
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Chiasma showing weakness ahead of PDUFA date for Mycapssa; shares down 10% premarket

Thinly traded micro cap Chiasma (NASDAQ: CHMA ) is off10%premarket on increased volume in response to a bearish article posted today by TheStreet's Adam Feuerstein. He says his sources tell him that the FDA will reject the company's marketing ...
 Seeking Alpha2 weeks ago

DURECT's REMOXY NDA accepted by the US FDA for review, with PDUFA date of 25 September 2016

Biopharmaceutical company DURECT Corporation (NasdaqGM:DRRX) stated on Tuesday that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for REMOXY (oxycodone capsules CII) for a substantive review. This US FDA ...
 Bloomberg2 weeks ago FDA Accepts REMOXY NDA for Review, Sets PDUFA Date of September 25, 2016  4 Traders2 weeks ago DURECT Announces FDA Acceptance of REMOXY® NDA, PDUFA Date of September 25, 2016  Sys-Con India2 weeks ago PAIN THERAPEUTICS : DURECT Announces FDA Acceptance of REMOXY® NDA, PDUFA Date of September 25, 2016  4 Traders2 weeks ago
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BRIEF-Merck says FDA has accepted for review supplemental biologics license application for Keytruda

April 13 Merck & Co Inc * Says fda granted priority review with a pdufa, or target action, date of aug. 9 * Says fda has accepted for review supplemental biologics license application (sbla) for keytruda Source text for Eikon: Further ...
 Reuters UK2 weeks ago FDA Accepts Merck's sBLA for KEYTRUDA® in Recurrent or Metastatic Head and Neck Cancer - Grants Priority Review  American Pharmaceutical Review2 weeks ago Merck's sBLA for KEYTRUDA accepted for review by the US FDA for recurrent or metastatic head and neck squamous cell carcinoma  Bloomberg2 weeks ago US FDA accepts for review Merck's sBLA for Keytruda to treat recurrent & metastatic HNSCC  PharmaBiz2 weeks ago
EuroInvestor

Nicox: 2015 Financial Results and Business Update

Latanoprostene bunod New Drug Application (NDA) under review by the U.S. Food & Drug Administration (FDA) with a PDUFA (Prescription Drug User Fee Act) date of July 21, 2016 AC-170 NDA to be submitted early Q2, 2016 2015 revenues ‚¬10 ...
 Bloomberg2 weeks ago LPCN: Awaiting June PDUFA Date  Yahoo! Finance3 weeks ago VALEANT PHARMACEUTICALS INTERNATIONAL, INC. - 10-K - Management's Discussion and Analysis of Financial Condition and Results of Operations  Pharmacy Choice3 days ago OPKO to Announce First Quarter Operating and Financial Results on May 9, 2016  Minyanville4 days ago
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FDA Pushes Back PDUFA Date for Dynavax's Hep B Vaccine HEPLISAV-B

Dynavax Receives Notification of PDUFA Extension for HEPLISAV-B to December 15, 2016 BERKELEY, CA -- (Marketwired) -- 04/27/16 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and Drug Administration (FDA) will ...
 BioSpace6 days ago Dynavax Receives Notification of PDUFA Extension for HEPLISAV-B to December 15, 2016  Nasdaq6 days ago BRIEF-Dynavax Technologies receives notification of PDUFA extension for Heplisav-B  Reuters UK6 days ago DYNAVAX TECHNOLOGIES : Receives Notification of PDUFA Extension for HEPLISAV-B to December 15, 2016  4 Traders6 days ago
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Synergy Pharmaceuticals Announces Acceptance of New Drug Application for Plecanatide, a Novel Uroguanylin Analog, in Chronic Idiopathic Constipation

PDUFA target action date of January 29, 2017 NEW YORK--(BUSINESS WIRE)--Apr. 19, 2016-- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) ...
 Bloomberg2 weeks ago FDA Accepts Synergy's NDA for Chronic Idiopathic Constipation Drug  PharmaceuticalProcessing1 week ago Synergy Pharma Announces Acceptance Of New Drug Application For Plecanatide, A Novel Uroguanylin Analog, In Chronic Idiopathic Constipation  BioSpace1 week ago
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CHIASMA INC : Impending PDUFA Dates Offer Opportunity for Large Move in Pharmaceutical Companies

/ Chiasma, Inc. (NASDAQ: CHMA), KemPharm, Inc. (NASDAQ: KMPH), Lipocine Inc. (NASDAQ: LPCN), and Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) have PDUFA dates scheduled over the next couple of months which could significantly alter the prospects for ...
 4 Traders3 weeks ago Impending PDUFA Dates Offer Opportunity for Large Move in Pharmaceutical Companies  Yahoo! Finance2 weeks ago Weekly Biotech Report Covering Opko Health Inc (NYSE:OPK) Intercept Pharmaceuticals (NASDAQ:ICPT) Gilead Sciences, Inc (NASDAQ:GILD) Clovis Oncology, Inc. (NASDAQ:CLVS) Chiasma, Inc. (NASDAQ:CHMA)  Yahoo! Finance3 weeks ago
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