FDA clears an Ezra 510(k) for its artificial intelligence-enabled Ezra Flash and its use in enhancing MR image quality.
CDER Office of New Drug Policy director Maarika Kimbrell leaves the agency to re-enter private legal practice at Morgan Lewis as a partner resident.
FDA places a clinical hold on a PepGen IND application for a Phase 1 trial of PGN-EDODM1 to treat myotonic dystrophy Type 1.
Precision BioScience says it will meet with FDA in June to discuss a regulatory way forward through a Phase 2 trial for its azer-cel in patients with ...
Sixteen advocacy organizations urge FDA to regulate laboratory-developed tests if Congress fails to produce a strong bill.
FDA completes a previously delayed pre-licensing inspection of China-based Shanghai Junshi Biosciences breakthrough cancer drug toripalimab manufactur...
FDA and the European Union agree to expand the scope of the U.S.-EU mutual recognition agreement to include inspections of veterinary pharmaceuticals.
FDA says that beginning 6/12 it will expand in-person industry meetings to include requests for Type B End-of-Phase 2 requests at CDER/CBER.
