CBER director Peter Marks overrides the review team in the 6/22 accelerated approval of Sarepta Therapeutics Duchenne muscular dystrophy gene therapy ...
FDA posts a draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations.
The Senate Appropriations Committee approves FDAs appropriations bill, which provides the agency a $20 million spending increase.
FDA sends Intercept Pharmaceuticals a second complete response letter on its NDA resubmission for obeticholic acid for treating pre-cirrhotic fibrosis...
FDA posts a final guidance entitled Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding ...
Federal Register notice: FDA releases a draft guidance entitled Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders U...
Jazz Pharmaceuticals sues FDA and seeks the reversal of a 5/1 approval of Avadel CNS Pharmaceuticals Lumryz, a sodium oxybate drug product citing Jazz...
Centers for Medicare & Medicaid Services (CMS) issues a proposed procedural notice outlining a new Medicare coverage pathway for breakthrough medical ...
