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...
FDA clears a DePuy Synthes 510(k) for the Velys Robotic-Assisted Solution and its use with the Attune Total Knee System.
FDA releases its latest batch of Warning Letters that includes one medical product company Bodyhealth.