FDA grants Albireo Pharma an orphan drug designation for A4250, an ileal bile acid transporter inhibitor for treating biliary atresia.
FDA researchers say efforts should be made to understand and account for potential bias in cancer drug patient-reported outcomes.
FDA Review posts product approval summaries for the week ending 1/18/2019.
FDA issues Immunomedics a complete response letter on its BLA for sacituzumab govitecan for treating patients with metastatic triple-negative breast c...
FDA commissioner Scott Gottlieb says the agency is curbing discretionary activities and looking to order furloughs in areas where the workload has dro...
Eli Lilly says a Phase 3 study of Lartruvo (olaratumab), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma, ...
FDA classifies as Class 1 a Medtronic recall of its Synergy Cranial Software and Stealth Station S7 Cranial Software due to reports of incorrect infor...
Prinston Pharmaceutical Inc. recalls one lot of irbesartan and seven lots of irbesartan hydrochlorothiazide tablets due to the detection of trace amou...