FDA Approves Drug for Autoimmune Neuropathies

September 13, 2025 由 AI 报道

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.

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.

Senate confirms Robert Califf as FDA commissioner

October 02, 2025 由 AI 报道

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 issues final rule on clinical trials diversity

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.