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About 800 results for "pdufa"

Joint BIO/PhRMA Statement on PDUFA Reauthorization

FDA and Manufacturers Map Out PDUFA Reform Priorities

A year-long process reauthorizing the Prescription Drug User Fee Act (PDUFA) was launched July 15, 2015 with a public meeting, setting the stage for monthly discussions with industry beginning this fall and regular meetings for FDA to hear the views ..., 1 week ago
FDA Seeks Smooth PDUFA Renewal Process, 1 week ago

FDA extends PDUFA date for review of cobimetinib NDA; Exelixis off 8%

Exelixis (EXEL -7.7%) slumps on average volume in response to the FDA's decision to extend its action date for its review of Genentech's (OTCQX:RHHBY) New Drug Application (NDA) for cobimetinib to November 11 from August 11. The agency feels that ...
 Seeking Alpha4 weeks ago Exelixis: FDA Extends PDUFA Action Date For Review Of NDA For Cobimetinib  RTTNews.com4 weeks ago FDA extends PDUFA date for Genentech's cobimetinib NDA  Center Watch3 weeks ago FDA taps the brakes on Genentech's cobimetinib review  FierceBiotech4 weeks ago

BioMarin Announces FDA Accepts Drisapersen NDA for Treatment of Duchenne Muscular Dys...

FDA Grants Priority Review Status FDA PDUFA Date is December 27, 2015 SAN RAFAEL, Calif., June 29, 2015 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced the U.S. Food and Drug Administration (FDA) has accepted for ...
 CNN Money1 month ago BioMarin (BMRN) Announces FDA Accepts Drisapersen NDA For Treatment Of Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping 6/29/2015  ClinicSpace1 month ago ZS Pharma Announces FDA Acceptance of ZS-9 New Drug Application  Pettinga Financial Advisors2 hours ago BioMarin and Sarepta move ahead with Duchenne candidates  Seeking Alpha4 weeks ago

Key PDUFA dates tomorrow for Amgen and Regeneron/Sanofi

7/23/2015, 7:48 PM (Source: Seeking Alpha) Tomorrow is the FDA's action (PDUFA)date for its review of regulatory filings submitted by Amgen and Sanofi. Sanofi's (SNY +1.2% ) NDA for cholesterol-lowering Praluent (alirocumab), ...
 TeleTrader.com6 days ago
Ecancer Medicalscience

Merrimack Pharmaceuticals Inc ( MACK )

U.S. FDA Grants Priority Review for MM-398 New Drug Application PDUFA date set for October 24, 2015 Merrimack seeking U.S. marketing approval of MM-398 for the treatment of patients with metastatic pancreatic cancer who have been previously ...
 Stock Junction1 month ago EU recommends dabrafenib/trametinib combo for treatment of melanoma  Ecancer Medicalscience1 day ago Tafinlar and Mekinist combination therapy achieves regulatory milestones  European Pharmaceutical Review2 days ago Novartis: Tafinlar, Mekinist Achieve EU, U.S. Regulatory Milestones  Nasdaq5 days ago

Agora's Latest Agora Financial's FDA Trader

at 10:46 AM EDT Agora is claiming a flaw in the stock market via the PDUFA (an acronym that originated with the Prescription Drug User Fee Act) that allows them to know in advance a magic date that the FDA will reveal critical information about a ...
 Minyanville5 days ago

PDUFA VI Negotiations Commence

Strengthening and exploring additional uses of the FDA's Sentinel System will be a top priority of PDUFA VI, agency officials said during a public meeting to kick off negotiations on reauthorization of the Prescription Drug User Fee Act. The ...
 FDA News1 week ago

FDA Law Blog - What's Next for Patient-Focused Drug Development?

The enactment of FDASIA, including the fifth reauthorization of PDUFA, really put patient engagement on the radar beyond some of the traditionally active disease communities (e.g., HIV/AIDS, cancer, neurological diseases). FDASIA's section 1137, the ...
 Friends of Cancer Research3 weeks ago Public Meeting on Patient-Focused Drug Development for Huntington's and Parkinson's Diseases  Pharmacy Choice1 week ago FDA's Patient-Focused Drug Development Initiative Selects Eight Diseases  FDA News2 weeks ago Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2016-2017  Pharmacy Choice3 weeks ago

FDA Accepts Opko Health (OPK)'s New Drug Application For Rayaldee 7/29/2015

MIAMI--( BUSINESS WIRE )--OPKO Health, Inc. (NYSE: OPK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review OPKO's New Drug Application (NDA) for calcifediol modified-release capsules (proposed ...
 ClinicSpace4 hours ago FDA accepts OPKO's NDA for rayaldee to treat CKD  Pharmaceutical Business Review6 hours ago OPKO Health's Rayaldee NDA accepted by US FDA for review  Bloomberg14 hours ago FDA Accepts OPKO's New Drug Application for Rayaldee  Reuters1 day ago

Edited Transcript of GILD earnings conference call or presentation 28-Jul-15 8:30pm GMT

Q2 2015 Gilead Sciences Inc Earnings Call FOSTER CITY Jul 29, 2015 (Thomson StreetEvents) -- Edited Transcript of Gilead Sciences Inc earnings conference call or presentation Tuesday, July 28, 2015 at 8:30:00pm GMT TEXT version of Transcript ...
 Yahoo! News11 hours ago Gilead Sciences' (GILD) CEO John Martin on Q2 2015 Results - Earnings Call Transcript  Seeking Alpha22 hours ago Edited Transcript of AMAG earnings conference call or presentation 23-Jul-15 12:00pm GMT  Yahoo! News5 days ago
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