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About 800 results for "pdufa"

Getting Into The Drug Business: From NDAs To PDUFA Dates
Benzinga.com

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.com, 3 days ago

25 images for pdufa

Benzinga.com, 3 days ago
Scrip Intelligence, 3 days ago
Scrip Intelligence, 1 week ago
European Pharmaceutical Review, 1 week ago
Freshnews.com, 2 weeks ago
Monthly Prescribing Reference, 4 weeks ago
Zacks.com, 3 weeks ago
BioPharma Dive, 3 weeks ago
Nasdaq, 3 weeks ago
Scrip Intelligence, 4 weeks ago
European Pharmaceutical Review

FDA extends PDUFA date for telotristat etiprate for the treatment of carcinoid syndrome

The will require additional time to complete its review of the new drug application for Lexicon Pharmaceuticals telotristat etiprate, an oral drug for the treatment of carcinoid syndrome. In a notice received from the FDA, the Prescription Drug ...
 European Pharmaceutical Review1 week ago BRIEF-Fitch places Monsanto Co's ratings on negative watch  Reuters UK2 weeks ago FDA delays PDUFA date for Lexicon's telotristat etiprate  Pharma Letter2 weeks ago BRIEF-FDA extends PDUFA date for Telotristat Etiprate  Reuters UK2 weeks ago
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BRIEF-Spectrum Pharmaceuticals says PDUFA date set for Qapzola NDA is Dec. 11

MOVES-Davis Advisors hires senior former Deutsche Bank ETF exec NEW YORK, Sept 14 Davis Advisors has hired a prominent exchange-traded fund executive, he said on Wednesday, as stock fund managers seek to enter the fast-growing ETF business. ...
 Reuters UK2 weeks ago Spectrum Pharmaceuticals says PDUFA date set for Qapzola NDA is Dec. 11  Reuters UK2 weeks ago FDA Advisory Committee Votes that Qapzola? (apaziquone) Has Not Shown Substantial Evidence of a Treatment Effect Over Placebo  Pharmacy Choice2 weeks ago SPECTRUM PHARMACEUTICALS : FDA Advisory Committee Votes that Qapzola (apaziquone) Has Not Shown Substantial Evidence of a Treatment Effect Over Placebo  4 Traders2 weeks ago
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FDA action date today for Aralez Pharma's resubmitted Yosprala marketing application; shares down 9%

Today is the FDA's PDUFA date for Aralez Pharmaceuticals' ( ARLZ -8.5%) resubmitted New Drug Application (NDA) seeking approval of YOSPRALA (aspirin + omeprazole) for the secondary prevention of cardiovascular disease in patients at risk for ...
 Seeking Alpha2 weeks ago What's Going On With Aralez Pharmaceuticals?  State Of The Markets.com2 weeks ago Aralez Pharmaceuticals Announces Its First Drug Acquisition  Seeking Alpha3 weeks ago

Technical Alert: Aralez Pharma Volatile Ahead PDUFA Panel On Yosprata

$6.80 - Monday high $6.49 - Tuesday high $6.45 - Intraday high as of 1:30 PM $5.70 - Current price as of 1:30 PM $4.89 - August 25 low $4.88 - August 26 low $4.78 - Intraday low as of 1:30 PM If content like this is useful to your ...
 Benzinga.com2 weeks ago
Schaeffers Research

Dynavax Technologies Corporation (NASDAQ:DVAX): Shares Soar as FDA Keeps PDUFA Date Unchanged

Although Food and Drug Administration (FDA) has abandoned the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to appraise the Biologics License Application (BLA) for HEPLISAV-B, the regulators informed Dynavax ...
 Bidness Etc3 weeks ago Dynavax Technologies Corporation (DVAX): Shares Soar as FDA Keeps PDUFA Date Unchanged  Equilibrio Informativo3 weeks ago Dynavax Technologies Could Capture Majority Share In The Hepatitis B Vaccination Market  Seeking Alpha3 weeks ago Dynavax Technologies Corporation ( DVAX )  Stock Junction3 weeks ago
Nasdaq

Dynavax Rebounds on Same PDUFA Date for Heplisav BLA

Shares of Dynavax Technologies Corporation DVAX bounced back after the company indicated that the FDA will review its Biologics License Application (BLA) for experimental hepatitis B vaccine, Heplisav on the current Prescription Drug User Fee Act ...
 Yahoo! Singapore3 weeks ago Dynavax says Heplisav-B PDUFA date of December 15 still a go; shares up 16% premarket  Seeking Alpha3 weeks ago
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Bay Area's Dynavax Plummeted After the FDA Cancels Advisory Meeting

Dynavax Provides Regulatory Update on HEPLISAV-B PDUFA Date of December 15, 2016, Remains Unchanged BERKELEY, CA --(Marketwired - September 04, 2016) - Dynavax Technologies Corporation (NASDAQ: DVAX ) announced today that the U.S. Food and ...
 BioSpace3 weeks ago BRIEF-Dynavax says PDUFA date for Heplisav-B remains unchanged  Reuters UK3 weeks ago Dynavax says PDUFA date for HEPLISAV-B remains unchanged  Pharmaceutical Business Review3 weeks ago Dynavax Provides Regulatory Update on HEPLISAV-B  Healthcare Sales & Marketing Network3 weeks ago

What Are Array Biopharma Inc (ARRY)'s Chances Of PDUFA Success?

Toggle navigation Markets News Tech Market Movers Futures Forex Macroeconomic Predictions Options Insider Trading Main Education Center Stock Screener Insider Purchases Insider Sales Browse Companies Latest 13D & 13G Filings ...
 InsiderMonkey.com4 weeks ago WHAT ARE ARRAY BIOPHARMA INC (NASDAQ : ARRY)'s Chances Of PDUFA Success?  4 Traders4 weeks ago
BioPharma Dive

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

TherapeuticsMD announced acceptance of the NDA for Yuvvexy (TX-004HR) by the FDA. TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women's healthcare company, today announced the acceptance of the NDA for Yuvvexy, the conditionally-approved ...
 Minyanville1 week ago THERAPEUTICSMD : Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy (TX-004HR)  4 Traders1 week ago BioMarin hits snag with latest rare disease drug  BioPharma Dive3 weeks ago TherapeuticsMD Announces Multiple Presentations Related to Yuvvexy (TX-004HR) at Two Upcoming Medical Conferences  Stockwatch1 week ago
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