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Taxpayer Group Calls for More Relaxed FDA

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The Taxpayers Protection Alliance calls on FDA to make changes in its regulation of drugs, tobacco, and foods to promote innovatio...

Bioanalytical Methods Template Available

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FDA announces availability of a technical specifications guidance with bioanalytical methods templates.

FDA OKs Gileads Descovy for HIV Prevention

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FDA approves Gilead Sciences Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for use in certain at-risk adults and ...

Nippon Shinyaku Completes Rolling NDA for Duchenne Drug

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Nippon Shinyaku completes submission of a rolling NDA for viltolarsen, a Duchenne muscular disease drug that is amenable to exon 5...

Biofourmis AI Physiological Monitor Cleared

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FDA clears a Biofourmis 510(k) for its machine-learning and artificial intelligence-powered Biovitals Analytics Engine as a medica...

Fed Reg Notice on Pemoline Corrected

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Federal Register notice: FDA corrects a 6/4 Federal Register notice withdrawing approval of five ANDAs for pemoline products becau...

FDA Denies Zydus Mephyton Petition

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FDA denies a Zydus petition asking it to take certain actions regarding new applications citing Mephyton as the reference-listed-d...

Orphan Drug Status for Verastems Copiktra

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FDA grants Verastem an orphan drug designation for Copiktra (duvelisib) for use in treating T-Cell lymphoma.

FDA Opens GDUFA Science and Research Web Page

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FDA debuts a Web page dedicated to FY 2018 GDUFA science and research outcomes.

Trump to Name Stephen Hahn FDA Commissioner: BioCentury

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BioCentury reports that President Trump will nominate MD Anderson Cancer Center chief medical officer Stephen Hahn to be the next ...