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About 800 results for "pdufa"

Medivation bullish on Xtandi as PDUFA approaches
BioPharma Dive

ARLZ: YOSPRALA® PDUFA Date is September 14, 2016

By David Bautz, PhD NASDAQ:ARLZ Financial Update On August 9, 2016, Aralez Pharmaceuticals, Inc. ( ARLZ ) reported financial results for the second quarter of 2016. The financial results for the corresponding periods in 2015 are those of ... Yahoo! Finance, 2 weeks ago
Medivation bullish on Xtandi as PDUFA approaches BioPharma Dive, 2 weeks ago

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The Industry Hopes Congress Approves PDUFA Program in 2016

Pharma and biotech companies worked hard this past year to reach agreement with FDA this month on a new version of the Prescription Drug User Fee Act (PDUFA VI); now theyd like Congress to approve the next five-year fee program before leaving ...
 PharmTech.com1 month ago

Two Under The Radar Biotech Decisions To Watch Next Month

August is going to be a big month in biotech, with a number of drugs up for FDA review. Here are two August PDUFAs that might fly under the radar, but that are worth watching as they roll around. BioThrax sBLA August 15. On August 15, the FDA ...
 InsiderMonkey.com1 month ago

What Is a PDUFA Date?

It's in the best interest of both pharmaceutical companies and patients to bring new drugs to the market as quickly as possible, which is why the Prescription Drug User Fee Act, or PDUFA, was established. Originally passed in 1992, PDUFA authorizes ...
 FOXBusiness.com1 month ago
Federal Register

PDUFA User Fees Fall for Fiscal 2017

Aug. 3, 2016 The FDA is lowering the cost of prescription drug submissions starting next fiscal year due to an anticipated rise in filings. When fiscal 2017 begins on Oct. 1, the cost of filing an NDA with clinical data will tumble more than ...
 FDA News3 weeks ago Devicemakers See Lower Fees in MDUFA 2017  FDA News3 weeks ago Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2017  Federal Register4 weeks ago FDA user fees dropping in FY17  PharmaVOICE1 month ago

Amid Trial Concerns, FDA Delays Approval Decision for Merck & Co.'s C. Diff Drug, New PDUFA Date Set

By Mark Terry , Breaking News Staff The U.S. Food and Drug Administration (FDA) , which was to make a decision on Merck ( MRK )'s pending Biologics Licensing Application (BLA) for bezlotoxumab tomorrow, has delayed a decision until ...
 BioSpace1 month ago How To Trade Durect Heading Into Remoxy Decision Date  Seeking Alpha3 weeks ago FDA Delays Decision on Merck C. difficile Candidate, Seeks More Data  Genetic Engineering News1 month ago Merck faces FDA delay for C. diff antibody amid trial data concerns  FierceBiotech1 month ago

Industry Says PDUFA Proposal Balances Innovation and Safety

The FDA's goals for the next version of PDUFA strike a balance between fostering innovation via real-world data usage while still preserving safety standards, PhRMA and BIO officials concluded after reviewing the agency's proposal. Under a draft ...
 FDA News1 month ago PDUFA Proposal Satisfies Companies by Accelerating Drug Approvals  FDA News1 month ago

The next PDUFA: New performance and procedural goals

A comprehensive look at performance and procedural objectives under the Prescription Drug User Fee Act (PDUFA) for fiscal years 201822 is now available. FDA's 46-page document explains how the agency will distribute user fees it receives from the ...
 Pharmacist.com1 month ago PDUFA 6 procedures will include patients, biomarkers for 2018-2022  BioPharma Dive1 month ago

Prescription Drug User Fee Act; Public Meeting; Request for Comments

, from 9 a.m. to 2 p.m. Please register for the meeting by August 8, 2016, at . Submit electronic or written comments to the public docket by August 22, 2016. The meeting and workshop will be held at ...
 Federal Register1 month ago FDA PDUFA VI goals expected to slow rate of user fee increases  Pharma Letter1 month ago BIO Statement on Prescription Drug User Fee Act Goals Letter  Minyanville1 month ago PhRMA Statement on Prescription Drug User Fee Act Reauthorization  American Pharmaceutical Outsourcing1 month ago
American Banking News - Earnings

Avalanche Biotechnologies Inc. (ADVM) Rating Reiterated by Jefferies Group

Avalanche Biotechnologies Inc. (NASDAQ:ADVM) s stock had its buy rating reissued by equities research analysts at Jefferies Group in a research note issued to investors on Wednesday. They currently have a $12.00 price target on the stock. Jefferies ...
 WKRB News2 weeks ago Jefferies Group Reiterates Buy Rating for Avalanche Biotechnologies Inc. (ADVM)  American Banking News - Earnings2 weeks ago Research Analysts Updated EPS Estimates for August, 10th (ADVM, ARDX, ARL, BCE, BEP, BTG, CNQ, COT, CTL, CYBR)  American Banking News - Earnings2 weeks ago Avalanche Biotechnologies (ADVM) Buy Rating Reiterated at Jefferies Group  Zolmax News2 weeks ago
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