FDA approves a Pfizer supplemental NDA for Xalkori (crizotinib) for adult and pediatric patients with unresectable, recurrent, or refractory inflammat...
A federal court has permanently enjoined a Colchester, VT, compounding pharmacy from distributing drugs unless they are manufactured in compliance wit...
FDA clears an Eko 510(k) for its Eko Murmur Analysis Software for use in its smart stethoscope for detecting and characterizing murmurs.
An FDA safety communication advises that testing for monkeypox virus should use swab samples taken directly from a lesion to avoid false test results.
Federal Register proposed rule: FDA proposes to revoke its methods of analysis regulation (21 CFR 2.19) that describes policy to use certain methods o...
Federal Register notice: FDA revokes the emergency use authorization issued to ScienCell Research Laboratories for its ScienCell SARSCoV2 Coronavirus ...
Federal Register notice: FDA makes available a final guidance entitled Instructions for UsePatient Labeling for Human Prescription Drug and Biological...
FDA approves a Provepharm NDA for Bludigo (indigotindisulfonate sodium), a diagnostic dye indicated for use as a visualization aid in the cystoscopic ...