FDA says the main causes of drug shortages continue to be manufacturing quality issues and manufacturing production delays.
FDA places a clinical hold on Mersana Therapeutics Phase 1 trial of XMT-2056 after the company suspended it due to a recent patient death that was dee...
FDA posts a final guidance entitled Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and C...
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.
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...
FDA splits into two its guidance entitled Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators Dur...
