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Sterling Drug Supply Chain Violations

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FDA warns Sterling Distributors about its multiple violations of the Drug Supply Chain Security Act.

Guide on Developing Drugs for Lyme Disease

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FDA posts a final guidance entitled Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment.

Lillys Amyvid Gets Updated Label

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FDA approves an updated label for Eli Lillys Amyvid (florbetapir F 18 injection) for brain imaging to estimate amyloid plaque dens...

FDA Approves New Warnings on Covid mRNA Vaccines

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FDA requires and approves updates to the prescribing information for Pfizers Comirnaty Covid-19 mRNA vaccine and Modernas Spikevax...

Stop FDAs Sudden Biosecurity Overreach: Newsletter

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A Global Biodefense online post says FDAs sudden decision to halt clinical trials that send samples overseas for processing can hu...

Makarys FDA Voucher Program Questioned

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UPenn medical school professor Holly Lynch says there are many questions about the new FDA Commissioners National Priority Voucher...

House Committee Advances FDA Budget Bill

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The U.S. House Appropriations Committee advances in a 35 to 27 vote FDAs fiscal year 2026 spending bill.

Safety Alert on Medtronic Esophagus pH Monitor

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FDA posts a safety alert on Medtronic subsidiary Given Imaging and certain Bravo CF Capsule delivery devices, which are designed t...

Safety Communication on 2 Elevidys-related Deaths

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FDA issues a safety communication about two reports of fatal acute liver failure following treatment of Duchenne Muscular Dystroph...

Nektar Sees Promising Data with Dermatitis Drug

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Nektar Therapeutics reports promising results from a mid-stage clinical trial of its experimental therapy rezpegaldesleukin for pa...