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About 800 results for "pdufa"

Kicking off the PDUFA VI Reauthorization Process

Kicking off the PDUFA VI Reauthorization Process

The Prescription Drug User Fee Act (PDUFA) authorizes FDA to collect fees from pharmaceutical companies to help fund the agency's drug review work. PDUFA's intent is to provide additional funding for FDA to hire staff, improve systems, and establish ..., 5 days ago
PDUFA VI Negotiations Commence FDA News, 1 month ago

9 images for pdufa, 5 days ago, 1 week ago, 3 weeks ago
Crawford Financial Planning, 1 month ago
Crawford Financial Planning, 1 month ago
PR Newswire, 1 month ago
PR Newswire, 1 month ago
European Pharmaceutical Review, 1 month ago
Pharmaceutical Business Review, 1 month ago

FDA extends PDUFA date for Genentech's cobimetinib NDA

Exelixis has been informed by partner Genentech , a member of the Roche Group , that, in order to accommodate its review of a supplemental data submission, the FDA has extended the Prescription Drug User Fee Act (PDUFA) action date for its review of ...
 Center Watch1 month ago Exelixis: FDA Extends PDUFA Action Date For Review Of NDA For Cobimetinib  RTTNews.com1 month ago

PDUFA date approaches for Alkermes' once-monthly antipsychotic

PDUFA date approaches for Alkermes' once-monthly antipsychotic The FDA's action date for its review of Alkermes' (ALKS -4% ) New Drug Application (NDA) seeking approval for aripiprazole lauroxil for the treatment of schizophrenia is August 22.
 TeleTrader.com1 week ago Key PDUFA dates tomorrow for Amgen and Regeneron/Sanofi  TeleTrader.com1 month ago

FDA accepts Merck's sBLA for expanded use of Keytruda, PDUFA date December 19

FDA accepts Merck's sBLA for expanded use of Keytruda, PDUFA date December 19 The FDA accepts for review the supplemental Biologics License Application (sBLA) from Merck (MRK -0.1% ) seeking approval for the use of Keytruda (pembrolizumab) as ...
 TeleTrader.com1 week ago FDA accepts InSite's BromSite NDA; PDUFA date April 10, 2016  TeleTrader.com1 week ago FDA says it needs more time to review Alkermes' aripiprazole lauroxil NDA  TeleTrader.com1 week ago FDA to decide on risky, controversial new female sex drug flibanserin (ADDYI)  Examiner.com1 week ago

Alkermes Posts 2Q 2015 Financial Results

Alkermes reported financial results for the second quarter of 2015. "With the PDUFA date for ARISTADA, our proposed brand name for aripiprazole lauroxil, just a few weeks away, we are in the midst of final launch preparations for this important ...
 4 Traders3 weeks ago Innocoll AG Announces Second Quarter 2015 Financial And Operating Results And Updates Late-Stage Product Portfolio Progress  TheStreet.com2 weeks ago Eagle Pharmaceuticals, Inc. Reports Second Quarter 2015 Results  TheStreet.com2 weeks ago Cleveland BioLabs Reports Second Quarter 2015 Financial Results and Development Progress  Sys-Con Media2 weeks ago

Hurdles Ahead for 'Cures' Legislation, PDUFA Renewal

Despite overwhelming House approval last month of the 21 st Century Cures Act, bipartisan support may fall apart in the coming months as key provisions face opposition in the Senate, negotiations begin on reauthorizing FDA drug user fees, and the ...
 PharmExec.com3 weeks ago Medicare, Medicaid, and Enforcement Implications of the 21st Century Cures Act Recently Passed by the House  JD Supra1 month ago House Passes 21st Century Cures Act: What Does it Mean for Clinical Research?  JD Supra1 month ago 21st Century Cures Act Provisions Relating to Digital Health: Interoperability and Information Blocking  JD Supra1 month ago

Tesaro licenses PDUFA-status candidate rolapitant to China's Jiangsu Hengrui

U.S.-based biotech Tesaro ( $TSRO ) has in-licensed China rights to its candidate to treat nausea in chemotherapy patients to China's Jiangsu Hengrui Medicine as it looks ahead to a pending review decision by the U.S. FDA . The candidate, ...
 Fierce Drug Delivery3 weeks ago Hengrui Medicine In-Licenses China Rights to Nausea/Vomiting Drug  Financial Content4 weeks ago Tesaro and Jiangsu Hengrui Medicine Announce Rolapitant License Agreement for China [Saudi Press Agency (Saudi Arabia)]  Pharmacy Choice3 weeks ago Tesaro, Inc. And Jiangsu Hengrui Medicine Co. Ltd. Announce Rolapitant License Agreement For China  BioSpace1 month 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 Research1 month ago Patient-Focused Drug Development for Nontuberculous Mycobacterial Lung Infections; Public Meeting  Pharmacy Choice3 weeks ago Public Meeting on Patient-Focused Drug Development for Huntington's and Parkinson's Diseases  Pharmacy Choice1 month ago FDA's Patient-Focused Drug Development Initiative Selects Eight Diseases  FDA News1 month ago

ZS Pharma Announces FDA Acceptance of ZS-9 New Drug Application

GlobeNewswire 2015-07-29 PDUFA date May 26, 2016 REDWOOD CITY, Calif., July 29, 2015 (GLOBE NEWSWIRE) -- ZS Pharma, Inc. (Nasdaq:ZSPH), today announced that its New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate) for the ...
 BizWire Express1 month ago FDA accepts ZS Pharma's NDA for ZS-9  TeleTrader.com1 month ago ZS PHARMA : Announces FDA Acceptance of ZS-9 New Drug Application  4 Traders1 month ago ZS Pharma (ZSPH) Announces FDA Acceptance Of ZS-9 New Drug Application 7/30/2015  ClinicSpace1 month 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 ...
 Minyanville1 month ago
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