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...
In a move linked to HHS secretary Robert F. Kennedy Jr., FDA suddenly cancels a 3/13-planned Vaccines and Related Biological Products Advisory Committ...
FDA grants fast-track designation for Adicet Bios ADT-001 to treat systemic sclerosis.
FDA releases the 19-page form FDA-483 with 15 observations from an inspection at the Exela Pharma Sciences outsourcing facility in Lenoir, NC.