FDA approves Genentechs Evrysdi (risdiplam) for treating spinal muscular atrophy in adults and children two months of age and older.
FDA clears a Joimax PMA for its Intracs, an electromagnetic navigation tracking and control system for spinal procedures.
California reaches a settlement agreement with AbbVie Inc. to resolve a lawsuit alleging violations of the California Insurance Frauds Prevention Act ...
FDA approves ViiV Healthcares Dovato (dolutegravir/lamivudine) for treating HIV-1 infection to replace the current three-drug antiretroviral regimen i...
FDA says a majority of postmarketing requirements and commitments are completed or moving toward completion on schedule.
Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...
Federal Register notice: FDA makes available a final guidance entitled Limited Population Pathway for Antibacterial and Antifungal Drugs.
The Rare Diseases Clinical Research Network says FDA should consider creating a Rare Diseases Clinical Trial Resource Center as a resource for existin...