FDA Official Addresses Autism Report Status

10. syyskuuta 2025 Raportoinut AI

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.

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.

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 issues final rule on clinical trials diversity

30. syyskuuta 2025 Raportoinut AI

The U.S. Food and Drug Administration has finalized a rule requiring drug sponsors to submit diversity action plans for clinical trials. This aims to ensure better representation of underrepresented groups in medical research. The rule takes effect in 2025.

FDA Approves New Schizophrenia Treatment

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.

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 Hypertension Detection Device

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.