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About 800 results for "pdufa"

Manufacturers Face Major Changes under PDUFA VI

Efforts to accelerate drug development will alter fee structure and require ready production sites. FDA officials and industry leaders have agreed on a set of recommendations for revising and updating the Prescription Drug User Fee Act (PDUFA) ..., 3 days ago

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Medtech Insight, 4 days ago, 1 week ago
BioSpace, 1 week ago
Nasdaq, 1 week ago
Yahoo! Singapore, 1 week ago, 3 weeks ago
Scrip Intelligence, 4 weeks ago
European Pharmaceutical Review, 1 month ago
Scrip Intelligence, 1 month ago, 1 month ago

Merck Has An Upcoming PDUFA Date For Bezlotoxumab

Merck & Co., Inc. (NYSE: MRK ) announced it has an upcoming PDUFA date on October 23. The FDA has accepted for review Merck's Biologics License application for Bezlotoxumab, an investigational antitoxin for the prevention of Clostridium difficile ...
 Benzinga.com3 days ago

How Do Recent Developments In The Approval Process For Heplisav-B By Dynavax Affect The Chances For A Positive PDUFA?

Inroduction Dynavax (NASDAQ: DVAX ) is developing Heplisav-B, a new vaccine for HBV (Hepatitis B virus) prevention. This vaccine utilizes a novel mechanism for stimulating the immune system which will allow the vaccine to protect from infection ...
 Seeking Alpha5 days ago Will Dynavax' Hepsilav-B Ever Get Approved?  Seeking Alpha1 week ago 10 Biotech Stocks to Put on Your Radar This Quarter  Nasdaq3 weeks ago Biotech Stock Mailbag: Dynavax, Puma, Ariad  TheStreet.com3 weeks ago

Why Egalet's FDA PDUFA Delay Is No Cause For Panic

Shares of Egalet Corp (NASDAQ: EGLT ) traded lower by more than 5 percent Monday morning after a scheduled meeting with the U.S. Food and Drug Administration (FDA) to discuss its delayed ARYMO ER therapy. Egalet said in a press release that the ...
 Benzinga.com1 week ago

The FDA Missed Egalet's PDUFA Date, But Investors Should Not Be Worried

Despite Thursday's FDA announcement that they'd miss the PDUFA date for Egalet Corp (NASDAQ: EGLT ), and Friday's sell-off in the stock, the biotech company's top analyst is still very bullish on the stock. Chiara Russo, Cantor Fitzgerald's ...
 Benzinga.com1 week ago

What Are Egalet Corp (EGLT)'s Chances Come PDUFA?

Egalet Corp (NASDAQ: EGLT ) had a pretty tough first couple of quarters, but the third quarter of 2016 was good to the company as sentiment shifted ahead of a major potential catalyst. The FDA accepted the company's new drug application (NDA) for ...
 InsiderMonkey.com2 weeks ago WHAT ARE EGALET CORP (NASDAQ : EGLT)'s Chances Come PDUFA?  4 Traders3 weeks ago Analysts Have Conflicting Sentiments on These Healthcare Companies: Egalet Corp (NASDAQ: EGLT), Alnylam Pharma (NASDAQ: ALNY) and United Therapeutics (NASDAQ: UTHR)  Analyst Ratings.com1 week ago IS EGALET CORP (NASDAQ : EGLT) A Discount Entry On Its FDA Delay?  4 Traders1 week ago

FDA queries Dynavax on Heplisav-B marketing application; PDUFA date remains December 15

In a regulatory filing , Dynavax (NASDAQ: DVAX ) reports that it has received requests for information from the FDA review team regarding its Biologics Licence Application (BLA) seeking approval of HEPLISAV-B [Hepatitis B Vaccine, Recombinant ...
 Seeking Alpha3 weeks ago

Getting Into The Drug Business: From NDAs To PDUFA Dates

The strongest catalysts for a pharma stock are the various milestones on the road to FDA approval for new drugs. For new investors, theyll often see a stock rise astronomically, but, when they go to make sense of the reasons for the jump, theyre ...
 Benzinga.com3 weeks ago

US FDA Considers Newron's Re-Submitted NDA for Xadago® to be a Complete, Class 2 Response to Complete Response Letter

MILAN--(BUSINESSWIRE)-- PDUFA date March 21, 2017 Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and ...
 Yahoo! Finance UK and Ireland4 days ago NEWRON PHARMACEUTICALS : US FDA considers Newron's re-submitted NDA for Xadago® to be a complete, class 2 response to Complete Response Letter PDUFA date March 21, 2017  4 Traders4 days ago U.S. FDA Considers Newron Pharma's Re-Submitted NDA For Xadago To Be A Complete, Class 2 Response To Complete Response Letter  BioSpace3 days ago Newron Announces FDA Response to Re-Submitted NDA for Xadago®  Uranium Investing News4 days ago

TherapeuticsMD Announces FDA Acceptance of New Drug Application NDA and Prescription Drug User Fee Act PDUFA Date for Yuvvexy? TX-004HR

By a News Reporter-Staff News Editor at Women's Health Weekly TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women's healthcare company, announced the acceptance of the NDA for Yuvvexy, the conditionally-approved trade name for TX-004HR, by ...
 Pharmacy Choice2 weeks ago THERAPEUTICSMD : Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy (TX-004HR)  4 Traders1 month ago TherapeuticsMD to Host Third Quarter Financial Results Conference Call and Webcast on November 3  SPi World News4 days ago THERAPEUTICSMD : to Host Third Quarter Financial Results Conference Call and Webcast on November 3  4 Traders4 days ago
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