FDA grants Caribou Biosciences a Regenerative Medicine Advanced Therapy designation for CB-010 and its use in treating relapsed or refractory large B ...
Federal Register notice: FDA announces a 1/24 Antimicrobial Drugs Advisory Committee meeting to vote on Cidara Therapeutics NDA for rezafungin.
Federal Register notice: FDA seeks nominations for voting members to serve on the Medical Devices Advisory Committee device panels.
FDA accepts for review a Sarepta Therapeutics BLA that is seeking accelerated approval for SRP-9001 (delandistrogene moxeparvovec) for treating ambula...
FDA clears a NeuroLogica 510(k) for its BodyTom 64 Point-of-Care Mobile Computed Tomography Scanner.
FDA releases a final guidance entitled Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantat...
FDA denies a petition seeking Risk Evaluation and Mitigation Strategiesfor Behrings simultaneously approved Hemophilia B gene therapy Hemgenix (etrana...
CDRH qualifies the CHemical RISk calculator Color Additives under its Medical Device Development Tools program.
