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) ... PharmTech.com, 3 days ago
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.com, 3 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 Alpha, 5 days ago Will Dynavax' Hepsilav-B Ever Get Approved? Seeking Alpha, 1 week ago 10 Biotech Stocks to Put on Your Radar This Quarter Nasdaq, 3 weeks ago Biotech Stock Mailbag: Dynavax, Puma, Ariad TheStreet.com, 3 weeks ago
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.com, 1 week ago
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.com, 1 week ago
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.com, 2 weeks ago WHAT ARE EGALET CORP (NASDAQ : EGLT)'s Chances Come PDUFA? 4 Traders, 3 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.com, 1 week ago IS EGALET CORP (NASDAQ : EGLT) A Discount Entry On Its FDA Delay? 4 Traders, 1 week ago
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 Alpha, 3 weeks ago
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.com, 3 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 Ireland, 4 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 Traders, 4 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 BioSpace, 3 days ago Newron Announces FDA Response to Re-Submitted NDA for Xadago® Uranium Investing News, 4 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 Choice, 2 weeks ago THERAPEUTICSMD : Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy (TX-004HR) 4 Traders, 1 month ago TherapeuticsMD to Host Third Quarter Financial Results Conference Call and Webcast on November 3 SPi World News, 4 days ago THERAPEUTICSMD : to Host Third Quarter Financial Results Conference Call and Webcast on November 3 4 Traders, 4 days ago
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