FDA

The FDA has cleared Dexcom’s Stelo Glucose Biosensor System for use by people ages 2 and older who do not use insulin. The decision, announced June 12, makes Stelo the first over-the-counter continuous glucose monitor approved for children.

29. mai 2026 Rapportert av AI

The U.S. FDA has approved Afrezza for children and adolescents with diabetes ages 6 and older. MannKind Corporation held a conference call on May 29, 2026, to discuss the decision.

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.

3. oktober 2025 Rapportert av AI

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.

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.

15. september 2025 Rapportert av AI

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.