[ Price : $8.95]
CBER director Peter Marks overrides the review team in the 6/22 accelerated approval of Sarepta Therapeutics Duchenne muscular dys...[ Price : $8.95]
FDA posts a draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations.[ Price : $8.95]
The Senate Appropriations Committee approves FDAs appropriations bill, which provides the agency a $20 million spending increase.[ Price : $8.95]
FDA sends Intercept Pharmaceuticals a second complete response letter on its NDA resubmission for obeticholic acid for treating pr...[ Price : $8.95]
FDA posts a final guidance entitled Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment...[ Price : $8.95]
Federal Register notice: FDA releases a draft guidance entitled Formal Dispute Resolution and Administrative Hearings of Final Adm...[ Price : $8.95]
Jazz Pharmaceuticals sues FDA and seeks the reversal of a 5/1 approval of Avadel CNS Pharmaceuticals Lumryz, a sodium oxybate drug...[ Price : $8.95]
Centers for Medicare & Medicaid Services (CMS) issues a proposed procedural notice outlining a new Medicare coverage pathway for b...