Roche/Genentech make suggestions for clarification and improvement to an FDA draft guidance on developing treatments for neovascular age-related macul...
CDRH asks for public comment on eight questions about using medical technologies in a home setting.
A New Jersey oncologist becomes the third doctor to plead guilty to participating in a scheme to purchase prescription oncology drugs under false pret...
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.
