FDA Approves New Drug Treatments: Latest Updates on Drug Approvals

The FDA has made several significant drug approvals recently. On November 24, 2025, durvalumab was approved for resectable gastric or gastroesophageal junction adenocarcinoma, expanding treatment options for patients with this aggressive cancer.

Additionally, pembrolizumab in combination with enfortumab vedotin-ejfv was approved on November 19, 2025, for muscle invasive bladder cancer, marking a major advancement in the management of this condition.

On the same day, the FDA approved selumetinib for adults with neurofibromatosis type 1, specifically for those with symptomatic, inoperable plexiform neurofibromas, providing a new therapeutic avenue for this patient population.

The FDA also granted traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis, a rare blood disorder, which represents a vital treatment option for patients.

On November 10, 2025, ziftomenib received approval for relapsed or refractory acute myeloid leukemia with an NPM1 mutation, enhancing treatment options for this challenging cancer type. Furthermore, sevabertinib received accelerated approval for non-squamous non-small cell lung cancer, and tarlatamab-dlle was granted traditional approval for extensive stage small cell lung cancer, both approvals showcasing the FDA's commitment to addressing critical needs in oncology.

This surge in approvals reflects an ongoing effort to provide innovative therapies that can significantly impact patient care. According to the FDA's Center for Drug Evaluation and Research, these developments also include revised guidance on monoclonal antibodies and extractables and leachables, crucial for ensuring drug safety and efficacy.

Overall, these advancements are poised to transform treatment landscapes across various medical fields, improving outcomes for countless patients.