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Labeling Changes for Testosterone Products: FDA

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FDA orders testosterone product makers to change their drug labeling to remove a warning about risk of adverse cardiovascular outc...

Lawyers Say Government Shutdown Could Stall Reviews

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FDAs ability to use its user fee carryover balances to fund product review operations during a potential government shutdown is un...

Odactra Approved for Expanded Use

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FDA approves an ALK supplemental BLA for Odactra (house dust mite allergen tablet) to expand its use for treating house dust mite-...

Zevra Selling Priority Voucher for $150 Million

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Zevra Therapeutics agrees to sell its Rare Pediatric Disease Priority Review Voucher for $150 million.

ROi CPS Recalls Newborn Kits

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ROi CPS recalls its newborn kits after receiving an Urgent Field Safety Notice for a kit component from supplier Mercury Medical.

Praxis to Finish Study Despite Data Miss

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Praxis Precision Medicines says it will continue a clinical trial despite an interim analysis recommendation that a clinical trial...

Bill to Block LDT Regulation

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Reps. Finstad and Crenshaw introduce legislation to stop FDA from regulating laboratory-developed tests.

FDA Warns Indias Granules Generic Drug Company

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An Indian news service says FDA has sent a Warning Letter to drug manufacturer Granules following a 2024 inspection at the firms f...

Ventec Recalls VOCSN Ventilators

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Ventec Life Systems recalls its VOCSN Multi-Function Ventilators because the devices were serviced using incorrect parts which can...

Makary FDA Confirmation Hearing Set for 3/6

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The Senate Health Education Labor & Pensions committee sets a 3/6 confirmation hearing to review the nomination of Johns Hopkins s...