FDA Clears Apple Watch Hypertension Detection

13. september 2025 Rapportert av AI

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.

Senate confirms Robert Califf as FDA commissioner

The U.S. Senate has confirmed Robert Califf to lead the Food and Drug Administration amid ongoing public health challenges. Califf, a cardiologist with prior FDA experience, was approved in a bipartisan vote. This move aims to stabilize the agency during debates over drug approvals and regulations.

FDA Approves New Schizophrenia Treatment

10. september 2025 Rapportert av AI

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.

Supreme Court upholds FDA approval of mifepristone

The U.S. Supreme Court unanimously ruled on June 13, 2024, that the FDA's approval of the abortion pill mifepristone is valid and remains in effect. The decision dismissed challenges from anti-abortion groups, affirming the agency's regulatory authority. This ruling ensures continued access to medication abortion, which accounts for more than half of U.S. abortions.

Senator Hawley criticizes FDA approval of new abortion drug

Republican Senator Josh Hawley from Missouri has sharply criticized the Food and Drug Administration for approving a new abortion drug, raising concerns about women's safety and the agency's trustworthiness. In a letter to FDA Commissioner Robert Califf, Hawley accused the agency of prioritizing politics over science. The move highlights ongoing debates over abortion access and regulatory oversight.

FDA Approves Drug for Autoimmune Neuropathies

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.

FDA Issues Breakthrough Designations

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.