Outgoing FDA commissioner Stephen Hahn says he was under significant White House pressure on Covid vaccines and treatments.
FDA issues an immediately effective guidance on methanol testing in drug products during the Covid-19 public health emergency.
Federal Register Final Rule: HHS issues a final rule under the Regulatory Flexibility Act that requires agencies like FDA to publish plans to conduct ...
FDA removes a partial clinical hold on a Pieris Pharmaceuticals Phase 1 study of PRS-343 that was issued while the company conducted an additional in-...
FDA commissioner Stephen Hahn and senior advisor Colin Rom say a new collaborative effort with the National Institute of Standards and Technology will...
DA releases a 39-page FDA-483 with 13 observations issued following a lengthy inspection at Lupins Somerset, NJ, drug manufacturing facility.
FDA grants accelerated approval to Janssen Biotechs Darzalex Faspro (daratumumab plus hyaluronidase) for combination use with bortezomib, cyclophospha...
FDA approves a Daiichi Sankyo BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) for certain adult patients with locally advanced or metastatic HER2-po...