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FDA OKs Dovato for Replacement HIV Regimen

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FDA approves ViiV Healthcares Dovato (dolutegravir/lamivudine) for treating HIV-1 infection to replace the current three-drug anti...

Majority of PMRs/PMCs On Schedule: Report

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FDA says a majority of postmarketing requirements and commitments are completed or moving toward completion on schedule.

Annual Report on Postmarketing Requirements/Commitments

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Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Co...

Final Guide on Limited Population Pathway

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Federal Register notice: FDA makes available a final guidance entitled Limited Population Pathway for Antibacterial and Antifungal...

Rare Disease Clinical Trial Resource Center Proposed

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The Rare Diseases Clinical Research Network says FDA should consider creating a Rare Diseases Clinical Trial Resource Center as a ...

FDA OKs Glaxo Myeloma Therapy

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FDA grants GlaxoSmithKline accelerated approval for Blenrep (belantamab mafodotin-blmf) for certain adult patients with relapsed o...

Ferring Recalls Desmopressin Due to Superpotency Concerns

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Ferring Pharmaceuticals recalls all lots of DDAVP (desmopressin) nasal spray 10 mcg/0.1mL, desmopressin acetate nasal spray 10 mcg...

Vaccine Decisions Based on Good Science, Data: Hahn

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FDA commissioner Stephen Hahn uses a Washington Post op-ed to reassure the public that any Covid-19 authorized for widespread use ...

Eight Charged in Clinical Trial Fraud Scheme

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The Justice Department says a federal grand injury has indicted eight people in a scheme to falsify FDA clinical trial data.

Experts Weigh-in on Covid Vaccine Deployment

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More than 250 scientific experts say FDA must thoroughly evaluate the completed Phase 3 trial results of any Covid-19 vaccine befo...