FDA

Inovio Pharmaceuticals held its first-quarter 2026 earnings call on May 13 to discuss financial results for the period ended March 31 and provide updates on its DNA medicines platform.

April 30, 2026 由 AI 报道

Syntara Limited held a shareholder webinar on April 29 to discuss FDA feedback on its proposed Phase IIb trial for amsulostat in myelofibrosis, along with a capital raise and quarterly report. CEO Gary Phillips highlighted the agreed path forward with regulators. The company lodged its Appendix 4C quarterly with the ASX.

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.

September 30, 2025 由 AI 报道

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.

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.

September 13, 2025 由 AI 报道 事实核查

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.