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.
The journal Science says safety questions are being raised about Eisai and Biogens lecanemab (BAN2401), an investigational anti-amyloid beta protofibr...
FDA sends Spectrum Pharmaceuticals a complete response letter rejecting the companys poziotinib and its use in treating certain patients with previous...
