Federal Register notice: FDA makes available a final guidance entitled Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier V...
FDA sends AstraZeneca a complete response letter on its supplemental BLA for Fasenra (benralizumab) for patients with inadequately controlled chronic ...
Federal Register notice: FDA determines that GE Healthcares MPI DMSA kidney reagent (Technetium Tc-99m Succimer Kit), Injectable, was not withdrawn fr...
FDA classifies as Class 1 a Baxter Healthcare recall of its Sigma Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusio...
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...