FDA amends the emergency use authorization for the Pfizer-BioNTech Covid-19 bivalent vaccine and its use as a single booster dose to include children ...
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...
Federal Register notice: FDA announces a 5/19 advisory committee meeting to discuss an Intercept Pharmaceuticals NDA for to nonalcoholic steatohepatit...
Federal Register notice: FDA seeks comments on an information collection extension entitled Custom Devices (OMB Control Number 0910-0767).
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.
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