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...
FDA approves Mercks Ontruzant (trastuzumab-dttb) as a biosimilar to Genentechs Herceptin (transtuzumab) for patients with HER2-overexpressing breast c...
FDA Webviews newsroom closes Monday (1/21) in observance of Martin Luther King day.
FDA clears an EBM Technologies 510(k) for its iPad Pro-based Rad System for diagnostic reading of radiological images.