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About 800 results for "pdufa"

Here's Why Sarepta Therapeutics Inc (SRPT) Stock Shot up Today
Bidness Etc

Sarepta Therapeutics Announces FDA Will Not Complete the Revie...

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that they are continuing ... CNBC, 1 day ago
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3 images for "pdufa"

Renal & Urology News, 9 hours ago
Bidness Etc, 1 day ago
MedPage Today, 2 weeks ago

BRIEF-Genmab - PDUFA target action date of September 10 for Ofatumumab

May 17 Genmab A/S : * Pdufa target action date of September 10, 2016 for Ofatumumab * Ofatumumab in combination with fludarabine and cyclophosphamide for relapsed CLL accepted for priority review by FDA Source text for Eikon: Further company ...
 Reuters UK1 week ago Genmab - PDUFA target action date of September 10 for Ofatumumab  Reuters UK1 week ago

LPCN: TLANDO PDUFA Date Six Weeks Away

By John Vandermosten, CFA NASDAQ:LPCN 1Q:16 Financial and Operational Results On May 9, 2016, Lipocine Inc. (LPCN) reported first quarter 2016 results, posting an operating loss of $7.0 million. This amount included $4.0 million of additional ...
 Yahoo! Finance1 week ago Lipocine Announces Financial and Operational Results for the First Quarter of 2016  Minyanville2 weeks ago
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Upcoming PDUFA and ANDA Approval Dates Could Catalyze Innovus Pharma (INNV) and Lipocine (LPCN)

) - Innovus Pharmaceutical, Inc. (OTCQB: INNV ) and Lipocine Inc. are two specialty pharmaceutical companies focused on men and women's health that have PDUFA and ANDA dates scheduled over the next few months that could significantly alter their ...
 BioMedReports3 days ago INNOVUS PHARMACEUTICALS : Upcoming PDUFA and ANDA Approval Dates Could Catalyze Innovus Pharma (INNV) and Lipocine (LPCN)  4 Traders1 week ago INNOVUS PHARMACEUTICALS : May 16, 2016Upcoming PDUFA and ANDA Approval Dates Could Catalyze Innovus Pharma (INNV) and Lipocine (LPCN)  4 Traders1 week ago 2 Small Biotechs To Buy Before Key PDUFA Dates  Seeking Alpha3 weeks ago
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Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%

- Potential Treatment for Patients with Facial Erythema (Redness) Associated with Rosacea - - Allergan Expects PDUFA Date in First Half 2017 - DUBLIN, May 24, 2016 /PRNewswire/ -- Allergan plc (AGN) today announced that the New Drug Application ...
 Yahoo! Finance2 days ago Allergan, Inc. (AGN) Receives Good News from Japan  InsiderMonkey.com2 days ago FDA accepts Allergan's NDA for oxymetazoline HCl cream; action date H1 2017  Seeking Alpha2 days ago US FDA accepts Allergan's NDA for oxymetazoline HCI cream 1.0%  PharmaBiz23 hours ago
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Monthly Prescribing Reference

FDA Continues Review of Controversial DMD Treatment

The FDA is continuing to review the NDA past the PDUFA goal date Sareptaannounced that theFood and Drug Administration(FDA) is continuing the pending New Drug Application (NDA) review for eteplirsen for the treatment of Duchenne muscular ...
 Monthly Prescribing Reference12 hours ago FDA to Review Topical Rosacea Treatment  Monthly Prescribing Reference2 days ago New Hypotension Treatment Approved  Pharmacy Times1 week ago

Why Sarepta's PDUFA Delay Is a Good Thing

Source: ThinkstockSarepta Therapeutics Inc. (NASDAQ: SRPT) shares saw a handy gain on Wednesday following an analyst upgrade. Janney Montgomery Scott has a Neutral rating on Sarepta but increased its fair value estimate to $18 from $10, based on a ...
 24/7 Wall St1 day ago Sarepta Therapeutics Surges 20% On No News  Benzinga.com6 days ago Analyst Review: Sarepta Therapeutics, Inc. (NASDAQ:SRPT)  Equilibrio Informativo2 weeks ago

Relypsa volatility elevated into ZS-9 PDUFA

Stock Market XML and JSON Data API provided by FinancialContent Services, Inc. Nasdaq quotes delayed at least 15 minutes, all others at least 20 minutes. Markets are closed on certain holidays. Stock Market Holiday List By accessing this page, ...
 BioSpace3 weeks ago Sarepta volatility elevated into PDUFA date for eteplirsen  Minyanville3 weeks ago
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Zacks.com

Novo Nordisk IDegLira Recommended by FDA Advisory Committee

Novo Nordisk NVO announced that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously (16-0) in favor of the approval of IDegLira for the treatment of adults with type II diabetes. IDegLira is a once-daily, ...
 Zacks.com1 day ago
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TeleTrader.com

FDA committee recommends approval of Novo Nordisk's IDegLira diabetes drug

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0, recommending the approval of Novo Nordisk's IDegLira for the treatment of adults with type 2 diabetes. IDegLira is a ...
 Pharmaceutical Business Review1 day ago FDA Panel Unanimously Backs Novo Nordisk A/S's Diabetes Combo Drug Ideglira  BioSpace1 day ago Novo's IDegLira receives positive vote  Nordic Life Science1 day ago IDegLira receives unanimous 16-0 vote in favor of approval from FDA Advisory Committee  PredictWallStreet2 days ago
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