FDA extends by three months the review of a Reata Pharmaceuticals NDA for omaveloxolone to allow time to evaluate additional data just submitted to th...
Federal Register notice: FDA renews its Allergenic Products Advisory Committee for an additional two years beyond the charter expiration date.
Federal Register notice: FDA determines that 50 listed drug products were not withdrawn for safety or effectiveness reasons.
The 2nd Circuit Court of Appeals says a New York federal court properly granted summary judgment to FDA and Sarepta in a Freedom of Information Act ca...
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...
