FDA says the Haimen Shengbang Laboratory Equipment recall of unapproved viral transport media containers is Class 1.
FDA attorney Heather Messick describes agency concerns with the European Union's General Data Protection Regulation.
FDA grants Attralus an orphan drug designation for 124 I-AT-01 iodine (evuzamitide) as a diagnostic for managing transthyretin amyloidosis.
FDA approves Myovant Sciences/Pfizers Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing moderate to severe pa...
Federal Register notice: FDA seeks comments on an information collection revision entitled "Q-Submissions Program for Medical Devices."
Federal Register notice: FDA announces a 9/22 Advisory Committee meeting to review a Rebiotix BLA for Rebyota (fecal microbiota, live) for reducing th...
FDA raises efficacy concerns about Reata Pharmaceticals May-submitted NDA for omaveloxolone, indicated for treating patients with Friedreichs ataxia....
A federal appeals court overturns a district court decision to dismiss, due to federal preemption, product liability claims under the Connecticut Prod...