December 2, 2022
The US Food and Drug Administration (FDA) has approved olutasidenib (Rezlidhia) for use in certain patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). Specifically, […]
December 1, 2022
Medtronic has issued a recall of the controller driveline cover of the company’s HeartWare Ventricular Assist Device (HVAD) system. The Medtronic HVAD system was approved as […]
December 1, 2022
The US Food and Drug Administration (FDA) has approved the first fecal microbiota product to prevent recurrence of Clostridioides difficile infection (CDI) in people aged 18 […]
November 29, 2022
Atezolizumab (Tecentriq) is no longer approved in the United States for use in certain patients with bladder or urinary tract cancer. The drug is an anti-PD-L1 […]
November 25, 2022
The US Food and Drug Administration (FDA) has announced that it will not approve poziotinib (Spectrum Pharmaceuticals) for the treatment of certain patients with nonsmall-cell lung […]
November 23, 2022
The U.S. Food and Drug Administration has approved etranacogene dezaparvovec (EtranaDez), the first gene therapy option for adults with hemophilia B who currently use factor IX prophylaxis therapy, […]
November 22, 2022
The US Food and Drug Administration (FDA) issued an alert today that cited preliminary evidence for a “substantial risk” for severe and symptomatic hypocalcemia and serious […]
November 18, 2022
The US Food and Drug Administration has approved the anti-CD3 monoclonal antibody teplizumab-mzwv (Tzield, Provention Bio) to delay the onset of clinical type 1 diabetes in […]
November 10, 2022
America’s Frontline Doctors is suing one of its founders in a battle for control over the controversial group, which gained national notoriety for spreading misinformation about […]