FDA Approves New Schizophrenia Treatment

10. september 2025 Rapporteret af 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.

FDA Clears Apple Watch Hypertension Detection

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.

Federal judge blocks expanded access to abortion pill mifepristone

A federal judge in Texas has issued a ruling limiting the FDA's approval of mifepristone, the primary drug used in medication abortions. The decision revives a long-standing lawsuit challenging the drug's safety and regulatory process. This comes amid ongoing legal battles over abortion access following the Supreme Court's overturning of Roe v. Wade.

Federal judge strikes down FDA limits on abortion pill

A U.S. federal judge in Maryland ruled that the FDA's restrictions on the abortion medication mifepristone were unlawful, benefiting plaintiffs from three states. The decision blocks requirements for in-person dispensing and a reduced gestational age limit. This preserves broader access to the drug used in most medication abortions.

FDA Grants Accelerated Approval for First Barth Syndrome Treatment

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.

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.

Supreme Court upholds FDA approval of mifepristone

30. september 2025 Rapporteret af AI

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.