April 1, 2025
The US Food and Drug Administration (FDA) has approved a perioperative durvalumab (Imfinzi, AstraZeneca) regimen for adults with muscle-invasive bladder cancer. Specifically, the indication is for […]
March 31, 2025
The US Food and Drug Administration (FDA) has expanded the approval for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) to include adults with prostate-specific membrane antigen […]
March 28, 2025
The US Food and Drug Administration has approved fitusiran for bleeding prophylaxis in hemophilia A and B with or without inhibitors. Fitusiran is a first-in-class small […]
March 28, 2025
An eye drop formulation intended to slow progression of myopia in children has been recommended for a marketing authorization by the European Medicines Agency (EMA). Ryjunea, […]
March 28, 2025
The European Medicines Agency (EMA) has recommended refusal of a marketing authorization for donanemab, which targets the treatment of early Alzheimer’s disease (AD). The agency’s Committee […]
March 28, 2025
The European Medicines Agency (EMA) has concluded a review of the weight loss drug naltrexone/bupropion (Mysimba), which was prompted by concerns about potential long-term cardiovascular risks. […]
March 27, 2025
The US Food and Drug Administration (FDA) has approved cabozantinib (Cabometyx, Exelixis, Inc.) for certain adults and children aged ≥ 12 years with previously treated, well-differentiated […]
March 25, 2025
The US Food and Drug Administration (FDA) approved guselkumab (Tremfya, Johnson & Johnson) for the treatment of adults with moderately to severely active Crohn’s disease (CD). […]
March 21, 2025
The US Food and Drug Administration (FDA) has approved a supplemental new drug application for vutrisiran for the treatment of wild-type or hereditary transthyretin-mediated amyloid cardiomyopathy […]