Regeneron Pharmaceuticals and AstraZeneca enter into a collaboration to research, develop and commercialize small molecule compounds directed against ...
King & Spalding attorneys analyze an FDA draft guidance on safety event analysis and reporting in IND and BE/BA studies.
FDA accepts for priority review an Aadi Bioscience NDA for its nanoparticle albumin-bound mTOR inhibitor Fyarro for treating advanced malignant PEComa...
FDA holds a Webinar to clarify agency thinking on the distinction between medical device servicing and remanufacturing and to consider cybersecurity i...
Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2022.
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Reporting 21 CFR Part 803.
Federal Register notice: FDA announces the animal drug user fee rates and payment procedures for fiscal year 2022.
FDA asks Pfizer and Moderna to expand vaccine tests in children under age 11 to better understand the risk for heart muscle inflammation.