Federal Register notice: FDA extends by two months the comment period on two proposed rules that appeared in the 9/28 Federal Register.
GSK says it has complied with an FDA request to restrict the second-line maintenance indication for cancer drug Zejula (niraparib).
The FTC files an amicus brief with the Delaware federal court in the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals, taking issue with a J...
FDA approves AstraZenecas Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy for treating adults with Sta...
FDA clears a DiaSorin 510(k) for its Simplexa Congenital CMV Direct kit, a molecular diagnostic test that detects cytomegalovirus DNA in saliva swab a...
FDA publishes a guidance on using definitions for device and counterfeit device.
FDA seeks comments on a draft guidance entitled Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5...
The CDER Office of Pharmaceutical Quality publishes a MAPP on its use of regulatory flexibilities to help overcome CMC readiness challenges for drug p...
