FDA extends by three months its review of Incytes supplemental NDA for Opzelura (ruxolitinib) cream for treating vitiligo.
FDA warns against using Apyx Medicals Renuvion/J-Plasma device for certain aesthetic procedures, such as those intended to improve the appearance of t...
FDA approves AstraZenecas Lynparza (olaparib) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mut...
FDA Review posts the Federal Register notices for the week ending 3/11/2022.
FDA Review posts product approval summaries for the week ending 3/11/2022.
Federal Register notice: FDA classifies the interoperable automated glycemic controller into medical device Class 2 (special controls).
FDA releases a five-page Form FDA-483 issued to Leesar Inc. following a 10/2021 inspection of the Fort Myers, FL outsourcing facility.