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FDA OKs Expanded Indication for Gaucher Disease Therapy

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FDA approves an expanded indication for Pfizer and Protalix BioTherapeutics Elelyso (taliglucerase alfa) for injection for treatin...

FDA OKs InnoPharma Dacogen Generic

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FDA approves an InnoPharma ANDA for decitabine for injection, a generic of Eisais Dacogne, indicated for treating patients with my...

Justice Dept. Calls Out PhRMA in Off-label Case

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The U.S. Department of Justice disputes a Pharmaceutical Research and Manufacturers of America brief asking a California federal c...

PhRMA Wants Risk, Efficacy Info Treated the Same

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PhRMA calls on FDA to use notice-and-comment rulemaking for new regulations about communicating new information about both drug ri...

FDA Lifts Clinical Hold on OncoMed Cancer Therapy

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FDA lifts a partial clinical hold against OncoMed Pharmaceuticals and enrollment in its vantictumab (anti-Fzd7, OMP-18R5) Phase 1 ...

FDA Denies Petition Seeking Tighter Megace Generic Bioequivalence

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FDA denies a citizen petition seeking tighter bioequivalence recommendations for generic versions of Bristol-Myers Squibbs Megace ...

Researchers Argue for Changes to QALY Cost-effectiveness Measure

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Tufts University researchers call for an update to the decades-old $50,000 quality-adjusted life-year (QALY) benchmark used in cos...

NCPDP Concerned About Non-traditional Drug Naming

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The National Council for Prescription Drug Programs tells FDA it has concerns about the agencys recent decision to give biological...

Group Wants Chantix Behind Pharmacy Counter

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Pharmacists Planning Service asks FDA to issue a regulation placing Chantix behind the pharmacy counter.

FDA Posts Draft Guide on BLA Lot Distribution eSubmissions

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FDA posts a draft guidance on Electronic Submission of Lot Distribution Reports.