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Drug Supply Security Info Collection

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Federal Register notice: FDA seeks comments on an information collection revision entitled Drug Supply Chain Security Act Implemen...

Omeza 510(k) for Collagen Wound Matrix

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FDA clears an Omeza 510(k) for its Omeza Collagen Matrix for chronic wound care.

Fraser Joins Greenberg Traurig

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Former FDA associate chief counsel for litigation James Fraser joins Greenberg Traurig.

Moderna Submits Covid Vaccine Booster Data to FDA

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Moderna submits trial data to FDA for an evaluation of its Covid vaccine booster shot.

House Chairs Want Aduhelm Info from FDA

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The chairs of two House committees ask FDA for detailed responses to 15 questions about the review and accelerated approval of Bio...

Takeda Reports Cancer Drugs Disappointing Trial Data

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Takeda Pharmaceutical reports disappointing data from its blood cancer Phase 3 PANTHER (Pevonedistat-3001) study, which did not ac...

FDA Accepts NDA for Wilsons Disease

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FDA accepts for review an Orphalan NDA for trientine tetrahydrochloride (TETA 4HCl) for the first-line treatment of Wilsons Diseas...

Petition Wants 2 Cassava Simufilam Trials Halted

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Attorney Jordan Thomas asks FDA to halt clinical trials of Cassava Sciences simufilam until the agency thoroughly evaluates the sc...

Panel to Review Prader-Willi Syndrome NDA

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Federal Register notice: FDA announces an 11/4 Psychopharmacologic Drugs Advisory Committee meeting to discuss a Levo Therapeutics...

FDA Orders New Warning on JAK Inhibitors

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FDA orders a drug class warning for Janus kinase inhibitors after reviewing a recent clinical trial that showed an increased risk ...