The U.S. Food and Drug Administration has granted approval for an injectable version of Merck's blockbuster cancer drug Keytruda, marking a significant advancement in treatment options for patients with certain types of cancer. This subcutaneous formulation promises greater convenience over the traditional intravenous method, potentially improving patient adherence and reducing healthcare burdens. The decision, announced on September 19, 2025, underscores ongoing innovations in oncology amid rising demands for more accessible therapies.

The U.S. Food and Drug Administration has granted accelerated approval to Forzinity, the first treatment for Barth syndrome, a rare X-linked genetic disorder primarily affecting males. Developed by Stealth Biotherapeutics, the therapy targets mitochondrial dysfunction underlying the condition, offering new hope for patients with this life-threatening disease. This milestone follows years of advocacy and highlights progress in addressing ultra-rare disorders.

The U.S. Food and Drug Administration has approved a new device for detecting hypertension, integrating advanced sensor technology. This innovation aims to improve early diagnosis and management of the condition.

The FDA approved a new drug for treating autoimmune neuropathies on September 9, 2025, accompanied by discoveries of new autoantibodies and effective complement inhibitors. This development ends 30 years of limited treatment progress in the field.

The US Food and Drug Administration granted clearance to Apple's new hypertension detection feature for the Apple Watch on September 11, 2025. The feature, announced at Apple's early September product launch, will be available in 150 countries starting next week.

The US FDA has approved a new treatment for schizophrenia that promises fewer side effects than existing options. This marks a significant step forward in mental health medication.

FDA Chief Marty Makary stated that an anticipated autism report has not yet been written, describing a Wall Street Journal story on the matter as premature. He indicated the report would be released within a month. Meanwhile, Kenvue's stock dropped following related news.

The FDA granted several breakthrough device designations in September 2025 for innovative medical technologies. These designations expedite the development and review of devices addressing unmet needs. Updates include new approvals and predetermined change control plans.