FDA warns healthcare professionals not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia pumps while the ag...
Janssen Pharmaceutical files a supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin and pemetrexed) for tre...
FDA issues Dr. Reddys Laboratories a 10-item Form FDA-483 after an inspection 10/27 at the firms Telangana, India manufacturing facility.
Federal Register notice: FDA makes available a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of...
Federal Register notice: FDA announces a 2/6/2024 advisory committee meeting on medical device supply chain resiliency and shortage issues.
Federal Register notice: FDA makes available a final guidance entitled Assessing the Credibility of Computational Modeling and Simulation (CM&S) in Me...
FDA approves an AstraZeneca NDA for Truqap (capivasertib) for use with fulvestrant in certain adult patients with hormone receptor-positive, human epi...
FDA approves a Merck NDA for Keytruda (pembrolizumab) and its use with fluoropyrimidine- and platinum-containing chemotherapy for treating certain adu...
