March 13, 2025
The US Food and Drug Administration (FDA) has approved the first biosimilar form of omalizumab (Xolair) for the treatment of a range of allergic conditions. Omalizumab-igec (Omlyclo) […]
March 5, 2025
The US Food and Drug Administration has approved tislelizumab (Tevimbra, BeiGene), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic […]
March 4, 2025
The US Food and Drug Administration (FDA) has approved the thrombolytic tenecteplase (TNKase, Genentech) for treatment of acute ischemic stroke in adults. The drug is administered […]
February 26, 2025
The US Food and Drug Administration (FDA) has expanded the indication for Tandem Diabetes Care’s Control-IQ+ Technology to include people with type 2 diabetes (T2D). The […]
February 24, 2025
The US Food and Drug Administration (FDA) has approved the first adaptive deep brain stimulation (aDBS) system for Parkinson’s disease (PD) that self-adjusts therapy to individual […]
February 21, 2025
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending fenfluramine (Fintepla) for treating seizures associated with Lennox-Gastaut syndrome. The recommendation […]
February 19, 2025
Medtronic has issued an “Urgent Medical Device Correction” about the accuracy of insulin pump delivery during changes in air pressure, such as airplane takeoffs and landings. […]
February 18, 2025
The US Food and Drug Administration (FDA) has approved Sanofi’s Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for treating adults and children with diabetes. The […]
February 14, 2025
The US Food and Drug Administration has approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC) to treat adult patients with symptomatic tenosynovial giant cell tumors (TGCT) who will […]