FDA approves an Acadia Pharmaceuticals NDA for Daybue (trofinetide) oral solution for treating Rett syndrome.
FDA and CDC send a letter to Florida surgeon general Joseph Ladapo to correct his misinterpretations and misinformation about Covid-19-related data.
Still evolving under the same leadership, Dickinsons FDA Webview asks subscribers to help guide our further development and improve service.
FDA clears a PeekMed 510(k) for its Web-based artificial intelligence automated planning solution for use in orthopedic surgery.
FDA says the main causes of drug shortages continue to be manufacturing quality issues and manufacturing production delays.
Federal Register notice: FDA announces a 4/17 Antimicrobial Drugs Advisory Committee meeting to discuss an Entasis Therapeutics NDA for sulbactam-durl...
A new Government Accountability Office report recommends that FDA better track the extent of its efforts to encourage drug manufacturers to adopt adva...
FDA publishes a Federal Register notice outlining the status of the many guidance documents that were issued to address the Covid-19 public health eme...
