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About 800 results for "pdufa"

Next Week In Biotech: Gilead, Celgene Report; PDUFAs For Thera...

Every week, Seeking Alpha aggregates expected biotech events in an effort to alert readers and contributors to upcoming catalysts. Crowdsourcing is key, so please let us know about any events we may have missed. Have a view on something that's ... Seeking Alpha, 3 days ago
16 Biotech Catalysts SunTrust Is Tracking, 2 weeks ago

9 images for pdufa

GlobeNewswire, 1 week ago
Canadian Business Journal, 1 week ago
I Stock Analyst, 1 week ago
Nasdaq, 2 weeks ago
ClinicSpace, 2 months ago
Pharmaceutical Business Review, 2 months ago
GlobeNewswire, 3 months ago
Nasdaq, 4 months ago
Seeking Alpha, 5 months ago

PR efforts at the FDA put the cart before the horse

Despite the fact that the FDA continues to perform woefully relative to its statute-defined target review goals by PDUFA and MDUFA, its campaign of public relations continues unabated. It is truly unprecedented to see the FDA Commissioner and high ...
 The Hill4 days ago
Canadian Business Journal

PDUFA goal date is November 30 for Repros' enclomiphene citrate

News Editor The FDA has assigned a PDUFA goal date of November 30 for the completion of its review of the New Drug Application (NDA) for Repros Therapeutics' (NASDAQ:RPRX) enclomiphene citrate (formerly Androxal) for the treatment of secondary ...
 Seeking Alpha1 week ago Repros Therapeutics Inc. (RPRX) Announces November 30, 2015 PDUFA Goal Date For New Drug Application 4/16/2015  ClinicSpace1 week ago Repros Announces November 30, 2015 PDUFA Goal Date for New Drug Application  Vision Monday1 week ago Repros Therapeutics : Announces November 30, 2015 PDUFA Goal Date for New Drug Application  4 Traders1 week ago

PDUFA date approaches for Kalydeco label expansion

Are you Bullish or Bearish on ? Bullish Bearish Results for ( ) Bullish Bearish Thanks for sharing your thoughts. Submit & View Results Skip to
 Seeking Alpha1 month ago

US FDA issues draft guidance on formal meetings for applicants of PDUFA products

The US FDA has issued draft guidance on the formal meetings between the FDA and sponsors or applicants of PDUFA products. The industry needs to revert to the global regulator by June end. This guidance provides recommendations to industry on ...
 PharmaBiz1 month ago Guidance Explains Expectations for Sponsor-FDA Meetings  FDA News1 month ago

Seattle Genetics, Inc. Release: FDA Accepts Supplemental BLA And Grants Priority Review For ADCETRIS (Brentuximab Vedotin) In The AETHERA Setting For The Post-Transplant Consolidation Treatment Of Hodgkin Lymphoma Patients At High Risk Of Relapse

-PDUFA Action Date August 18, 2015- -Submission of Supplemental BLA Based on Positive Phase 3 AETHERA Clinical Trial Results Recently Published in The Lancet- BOTHELL, Wash.--( BUSINESS WIRE )-- Seattle Genetics, Inc.
 BioSpace6 days ago FDA Accepts Supplemental BLA and Grants Priority Review for ADCETRIS┬« (Brentuximab Vedotin) in the AETHERA Setting for the Post-Transplant Consolidation Treatment of Hodgkin Lymphoma Patients at High Risk of Relapse  Morningstar.com1 week ago FDA accepts Seattle Genetics' filing for Adcetris expanded indication  Seeking Alpha6 days ago SEATTLE GENETICS : FDA Accepts Supplemental BLA and Grants Priority Review for ADCETRIS┬« (Brentuximab Vedotin) in the AETHERA Setting for the Post-Transplant Consolidation Treatment of Hodgkin Lymphoma Patients at High Risk of Relapse  4 Traders1 week ago

3 Potential Blockbuster Drugs That Could Be Approved Before Year's End

Todd Campbell: One of the most anticipated PDUFA dates this year has to be July 24, because that's when the FDA is set to make its decision on Regeneron Pharmaceuticals and Sanofi's Praluent. If approved, Praluent will give doctors a new weapon they ...
 Austin American Statesman1 week ago
Motley Fool

This Is the Reason for Biotech's Monster Run, and It Isn't Going Away Anytime Soon

The Prescription Drug User Fee Act, or PDUFA, which has been renewed by Congress four times, requires drug companies to pay fees to have their marketing applications reviewed. During the first two years of PDUFA V, the fifth iteration of the act, ...
 Austin American Statesman2 weeks ago The Real Reason For Biotech's Monster Run, And It Isn't Going Away Anytime Soon  BioSpace1 week ago

Amgen Ticks All The Boxes For A Perfect Investment

Amgen has seen robust sales growth over the last five years which is better than the industry average. Amgen has also consistently increased shareholder distributions. The company's strong pipeline means that it can continue to see consistent ...
 Seeking Alpha1 hour ago
Pharmaceutical Online

FDA Grants Priority Review to Kyprolis for Multiple Myeloma

The Food and Drug Administration has granted Priority Review designation to Kyprolis (carfilzomib) for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. Image Tools Kyprolis is currently ...
 Oncology Times2 days ago FDA News Roundup: Teva, AstraZeneca, Amgen, Medicines Company, And More  Pharmaceutical Online1 week ago FDA Grants Amgen Priority Review for Kyprolis Carfilzomib Supplemental New Drug Application for the Treatment of Relapsed Multiple Myeloma  Pharmacy Choice1 week ago Teva (TEVA) And Eagle Pharmaceuticals (EGRX) Announce NDA For Bendamustine Rapid Infusion Product Accepted For Filing 4/14/2015  ClinicSpace1 week ago
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