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Senate HELP Committee: 15 Ways to Reform FDA

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

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Biologics

Debate Intensifies Over Politicization of mRNA Vaccines

FDAs refusal to review Modernas mRNA influenza vaccine reignites concerns that vaccine policy particularly involving mRNA technology is becoming inc...

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Human Drugs

FDA DTC Crackdown Reshapes Industry Creative Approach

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

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Human Drugs

Rare Disease Innovation Hub 2026 Strategic Agenda

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

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Human Drugs

CGMP Issues at Australias Cosmetic Manufacturers Pty

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

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Human Drugs

Compass Pathways Reports 2nd Positive Trial for Depression Drug

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

Medical Devices

Trividia True Metrix Glucose Monitor Early Alert

An FDA Early Alert says Trividia Health has issued updated use instructions for its True Metrix blood glucose monitors to emphasize the need to seek i...

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Animal Drugs

FDA Warns Elanco Animal Health About Pradalex Ads

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

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Human Drugs

BMS Files NDA for Multiple Myeloma

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

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Human Drugs

FDA Should Move More Drugs OTC: Opinion

Singer further suggests that Congress could explore forms of international drug reciprocity, allowing Americans to purchase certain drugs over the cou...