FDA accepts for priority review an Aadi Bioscience NDA for its nanoparticle albumin-bound mTOR inhibitor Fyarro for treating advanced malignant PEComa...
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.
FDA approves a 30th indication for Mercks Keytruda, this time for use with chemotherapy in some breast cancers before and after surgery.
FDA gives 510(k) clearance to LifeSignals Groups LifeSignals ECH remote monitoring patch platform to detect common cardiac arrhythmias.
FDA will meet with Petros over proposed labeling changes for the companys Stendra erectile dysfunction medicine.