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...
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...
A JAMA Oncology article discusses a collaboration between FDA, the National Cancer Institute, and patient and industry representatives that has develo...
FDA approves a Daiichi Sankyos Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for treating patients with unresectable or metastatic HER2-lo...
FDA issues Acadia Pharmaceuticals a second complete response letter on its supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations an...
