Federal Register notice: FDA announces a 6/9-10 Cellular, Tissue and Gene Therapies Advisory Committee meeting to discuss two bluebird bio BLAs.
Federal Register notice: FDA makes available two final device-specific guidance documents for the Safety and Performance Based Pathway.
Federal Register notice: FDA permanently debars Lisett Raventos from providing services in any capacity related to an approved or pending drug product...
FDA publishes a final guidance on its approach to enforcement involving animal drugs compounded from bulk drug substances.
Pro golfer James Hahn is partnering with IBSA Pharma to promote its Licart prescription topical NSAID.
FDA grants Safer Technologies Program designation for a Pear Therapeutics pain control device.
Aeglea BioTherapeutics files a BLA for pegzilarginase for treating Arginase 1 Deficiency.
FDA approves a Boston Scientific PMA for its latest image guided programming software, Vercise Neural Navigator with StimViewXT, for use in brain stim...