[ Price : $8.95]
Federal Register notice: FDA extends by two months the comment period on two proposed rules that appeared in the 9/28 Federal Regi...[ Price : $8.95]
GSK says it has complied with an FDA request to restrict the second-line maintenance indication for cancer drug Zejula (niraparib)...[ Price : $8.95]
The FTC files an amicus brief with the Delaware federal court in the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals, t...[ Price : $8.95]
FDA approves AstraZenecas Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy for trea...[ Price : $8.95]
FDA clears a DiaSorin 510(k) for its Simplexa Congenital CMV Direct kit, a molecular diagnostic test that detects cytomegalovirus ...[ Price : $8.95]
FDA publishes a guidance on using definitions for device and counterfeit device.[ Price : $8.95]
FDA seeks comments on a draft guidance entitled Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human...[ Price : $8.95]
The CDER Office of Pharmaceutical Quality publishes a MAPP on its use of regulatory flexibilities to help overcome CMC readiness c...