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PharmaTher Resubmits Ketamine NDA

[ Price : $8.95]

PharmaTher also said it was working with its third-party manufacturing partner to resolve the deficiencies.

Olympus Recalls Endoscope Guide Sheaths

[ Price : $8.95]

Olympus recalls certain models of its endoscope single use guide sheath kits after receiving complaints about the radiopaque tip f...

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

ROi CPS Recalls Newborn Kits

[ Price : $8.95]

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...