FDA

Realistic illustration of FDA biologics chief Dr. Vinay Prasad departing agency headquarters, with calendar and biologics symbols.

FDA biologics chief Vinay Prasad to leave agency at end of April

7. März 2026 Von KI berichtet Bild generiert von KI Fakten geprüft

Dr. Vinay Prasad, who leads the FDA division that oversees vaccines and other biological products, will leave the agency at the end of April, FDA Commissioner Marty Makary told staff in an email. It will be Prasad’s second departure in less than a year after a brief exit last summer amid clashes over high-profile drug and vaccine reviews.

Inovio Pharmaceuticals reviews Q1 results and INO-3107 FDA status

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.

Syntara reports positive FDA feedback on amsulostat trial

30. April 2026 Von KI berichtet

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.

Gesundheit

Federal judge strikes down FDA limits on abortion pill

Gesundheit

Federal judge blocks expanded access to abortion pill mifepristone

Politik

Senator Hawley criticizes FDA approval of new abortion drug

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.

Supreme Court upholds FDA approval of mifepristone

30. September 2025 Von KI berichtet

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.

FDA Approves Drug for Autoimmune Neuropathies

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.

FDA Clears Apple Watch Hypertension Detection

13. September 2025 Von KI berichtet Fakten geprüft

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.

Montag, 13. April 2026, 22:13 Uhr