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FDA Reorg Could Hurt Supplements: Duncan

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South Carolina GOP Rep. Jeff Duncan says FDA should retain the Office of Dietary Supplement Programs as a freestanding entity rath...

FDA Approves RSV Vaccine for Pregnant Women

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FDA approves Pfizers RSV vaccine Abrysvo for use in pregnant women to protect infants from birth to 6 months of age.

Nurami Dura Mater Repair Graft Cleared

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FDA clears a Nurami Medical 510(k) for its ArtiFascia Dura Substitute, a resorbable dura mater repair graft.

Drug Shortages are National Security Risk: Califf

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FDA commissioner Robert Califf tells an Alliance for a Stronger FDA webinar that ongoing drug shortages are a huge national securi...

Oncologic Panel to Review Amgens Lumakras

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Federal Register notice: FDA announces a 10/5 Oncologic Drugs Advisory Committee meeting to discuss an Amgen supplemental NDA for ...

OTC Devices Dont Need Patient Self-Diagnosis: CHPA

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The Consumer Healthcare Product Association tells CDRH patient self-diagnosis need not be a requirement for the at-home use of ove...

FDA Approves Ingrezza for Huntingtons Chorea

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FDA approves a Neurocrine Biosciences NDA for Ingrezza (valbenazine) capsules for treating adults with chorea associated with Hunt...

FDA Partial Hold on Gileads Magrolimab

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FDA places a partial clinical hold on Gilead Sciences studies evaluating magrolimab to treat acute myeloid leukemia.

NDA for Myelodysplastic Syndromes Anemia

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FDA accepts for review a Geron NDA for imetelstat, a potential first-in-class telomerase inhibitor for treating transfusion-depend...

2 Drug Substance Nixed For Compounding

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Federal Register notice: FDA decides not to add ephedrine sulfate and hydroxychloroquine sulfate to its list of bulk drug substanc...