The DC federal court orders FDA to act on a Vanda sNDA for a Hetlioz indication to treat jet lag disorder or schedule a hearing on the submission.
FDA posts a guidance entitled Considerations for the Development of Chimeric Antigen Receptor T Cell Products.
FDA releases a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Product...
Federal Register notice: FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments Question and Answers.
Federal Register notice: FDA makes available a final document entitled Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human ...
FDA says that beginning 3/8, Pfizers Paxlovid that is labeled under a 12/2021 emergency use authorization will no longer be authorized for adults, and...
U.S. Senator Tammy Baldwin (D-WI) writes the four biggest drug companies marketing asthma inhalers urging them to stop unfairly blocking generics from...
Merck says its Phase 3 KEYNOTE-564 trial evaluating Keytruda (pembrolizumab) as an adjuvant treatment in patients with renal cell carcinoma saw an imp...
