FDA issues final rule on clinical trials diversity

30. September 2025 Von KI berichtet

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.

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 Official Addresses Autism Report Status

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.

FDA Approves Injectable Form of Merck's Keytruda

22. September 2025 Von KI berichtet

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.

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 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.