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Rare Disease Innovation Hub 2026 Strategic Agenda

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The FDA Rare Disease Innovation Hub sets eight action items for 2026.

BMS Files NDA for Multiple Myeloma

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FDA accepts for priority review a Bristol Myers Squibb NDA for iberdomide in combination with daratumumab and dexamethasone for pa...

Debate Intensifies Over Politicization of mRNA Vaccines

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FDAs refusal to review Modernas mRNA influenza vaccine reignites concerns that vaccine policy particularly involving mRNA technol...

FDA Warns Elanco Animal Health About Pradalex Ads

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The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its P...

CGMP Issues at Australias Cosmetic Manufacturers Pty

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FDA warns Australias Cosmetics Manufacturers about CGMP violations in its production of drugs as a contract manufacturer.

Compass Pathways Reports 2nd Positive Trial for Depression Drug

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Compass Pathways reports that its investigational psilocybin therapy met the primary endpoint in a second pivotal Phase 3 trial fo...

Trividia True Metrix Glucose Monitor Early Alert

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An FDA Early Alert says Trividia Health has issued updated use instructions for its True Metrix blood glucose monitors to emphasiz...

Senate HELP Committee: 15 Ways to Reform FDA

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The Senate HELP Committee offers an initial 15 recommendations for reforming FDA as part of what it says will be a collaborative, ...

FDA DTC Crackdown Reshapes Industry Creative Approach

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Drug advertising consultant Bob Ehrlich says the recent wave of FDA enforcement letters on drug promotion activities is reshaping ...

FDA Shifts to Risk-Based Device Inspections under QMSR

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As part of FDAs recent implementation of the Quality Management System Regulation, a new risk-based inspection model is set to cha...