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 […]
February 14, 2025
The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (EMA) has started a review of medicines containing finasteride and dutasteride following concerns about associated suicidal […]
February 12, 2025
The US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for brentuximab vedotin (Adcetris; Seagen, Inc., a Pfizer subsidiary), in combination with […]
February 12, 2025
The US Food and Drug Administration (FDA) has approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.) for certain adult and pediatric patients with neurofibromatosis type 1 (NF1). Specifically, […]
February 6, 2025
The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood glucose level alerts from diabetes-related smartphone devices […]
February 3, 2025
The US Food and Drug Administration (FDA) has approved Avtozma (tocilizumab-anoh) as a biosimilar of the original reference biologic tocilizumab (Actemra), according to a January 30 […]
January 31, 2025
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended that marketing authorizations be approved for three new cancer drugs: […]
January 31, 2025
The US Food and Drug Administration (FDA) has approved a novel formulation combining rizatriptan and the nonsteroidal anti-inflammatory drug meloxicam (Symbravo, Axome Therapeutics) for the acute […]