FDA Updates on Drug Approvals and Safety Warnings

The FDA has recently updated its drug approval and safety warning information, indicating a proactive stance in enhancing patient safety and expanding treatment options. Notably, the FDA approved several novel drugs in 2025, including lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma, and durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma.

Additionally, the FDA granted traditional approval for daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis and accelerated approval to sevabertinib for non-squamous non-small cell lung cancer.

In terms of safety, the FDA issued a public notification about the product mR.7 SUPER 700000, which was found to potentially contain harmful hidden drug ingredients. Furthermore, the agency provided draft guidance on monoclonal antibodies and extractables and leachables, aiming to streamline nonclinical safety studies and enhance safety protocols in drug manufacturing.

These updates reflect the FDA's ongoing commitment to improving healthcare outcomes through rigorous drug evaluation and safety monitoring.