FDA Approvals and New Drug Developments Update

The FDA has recently approved several significant treatments across various medical fields. On November 24, 2025, the FDA approved durvalumab for patients with resectable gastric or gastroesophageal junction adenocarcinoma, enhancing treatment options for this aggressive cancer type.

Additionally, pembrolizumab in combination with enfortumab vedotin-ejfv received approval on November 19, 2025, specifically for muscle invasive bladder cancer, marking a notable advancement in oncological therapies.

The FDA also granted traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis, a condition that can lead to severe organ damage. On November 10, 2025, ziftomenib was approved for relapsed or refractory acute myeloid leukemia with an NPM1 mutation, providing hope to patients with this difficult-to-treat leukemia.

Furthermore, selumetinib was approved for adults with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas, a significant step for those affected by this genetic disorder. In lung cancer treatments, sevabertinib received accelerated approval for non-squamous non-small cell lung cancer, while tarlatamab-dlle received traditional approval for extensive stage small cell lung cancer, both on November 19, 2025.

The FDA has also highlighted a public notification regarding mR.7 SUPER 700000, indicating potential harm due to hidden drug ingredients, emphasizing the importance of rigorous drug safety evaluations.

The FDA continues to update its databases, including the National Drug Code Directory and the Orange Book, which lists approved drug products with therapeutic equivalence evaluations. The agency's commitment to providing draft guidance on extractables and leachables is evident from the guidelines published on November 25, 2025.

Overall, these updates reflect the ongoing evolution of drug treatments and the FDA's dedication to ensuring patient safety and access to innovative therapies.