FDAs ability to use its user fee carryover balances to fund product review operations during a potential government shutdown is unlikely because of se...
FDA approves an ALK supplemental BLA for Odactra (house dust mite allergen tablet) to expand its use for treating house dust mite-induced allergic rhi...
Zevra Therapeutics agrees to sell its Rare Pediatric Disease Priority Review Voucher for $150 million.
ROi CPS recalls its newborn kits after receiving an Urgent Field Safety Notice for a kit component from supplier Mercury Medical.
Praxis Precision Medicines says it will continue a clinical trial despite an interim analysis recommendation that a clinical trial evaluating ulixacal...
Reps. Finstad and Crenshaw introduce legislation to stop FDA from regulating laboratory-developed tests.
An Indian news service says FDA has sent a Warning Letter to drug manufacturer Granules following a 2024 inspection at the firms facility in Gagillapu...
Ventec Life Systems recalls its VOCSN Multi-Function Ventilators because the devices were serviced using incorrect parts which can lead to device shut...
