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FDA Accepts Allergan sNDA for Dalvance

[ Price : $8.95]

FDA accepts for filing an Allergan supplemental NDA for Dalvance (dalbavancin) that seeks approval for a single-dose administratio...

FDA OKs Opdivo for Lung Cancer

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FDA approves a Bristol-Myers Squibb NDA for Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung ca...

Cirara Reduces Death Chances from Stroke: Study

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A Phase 2 study involving Remedy Pharmaceuticals Cirara (glyburide intravenous) finds that the drug reduces the chance of dying fr...

FDA Clears BioFure Meningitis/Encephalitis Test Panel

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FDA approves a BioFire Diagnostics de novo petition to allow the marketing of its FilmArray Meningitis/Encephalitis Panel, a cereb...

FDA Should Remove Bayers Essure from Market: Rep. DeLauro

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Rep. Rosa DeLauro urges FDA to remove Bayers controversial Essure contraceptive due to the thousands of adverse events submitted t...

Bernie Sanders Opposes Califf as FDA Commissioner

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Senator and presidential candidate Bernie Sanders (I-VT) says he will vote against confirming Robert Califf as FDAs next commissio...

New DTC Study on Quantitative Info in TV Ads

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FDA plans to conduct on Quantitative Information in Direct-to-Consumer Television Advertisements, which aims to test consumers und...

Ostroff Praises Forensic Chemistry Center

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FDA acting commissioner Stephen Ostroff praises the work of the agencys Forensic Chemistry Center over the last 25 years and pledg...

Info on Formal Sponsor Meetings Sent to OMB

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Federal Register Notice: FDA submits to the Office of Management and Budget a collection of information in a guidance on formal me...

Info on Dispute Resolution Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a guidance on formal dispute resolution and appeals a...