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. marts 2026 Rapporteret af AI Billede genereret af AI Faktatjekket

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.

Syntara reports positive FDA feedback on amsulostat trial

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.

FDA approves Travere Therapeutics' FILSPARI for FSGS

13. april 2026 Rapporteret af AI

The U.S. Food and Drug Administration approved FILSPARI, developed by Travere Therapeutics, as the first medicine for focal segmental glomerulosclerosis (FSGS). Travere announced the approval on April 13, 2026. Company executives held a business update conference call that evening to discuss the milestone.

Sundhed

Federal judge blocks expanded access to abortion pill mifepristone

Politik

Senator Hawley criticizes FDA approval of new abortion drug

Sundhed

Senate confirms Robert Califf as FDA commissioner

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.

FDA issues final rule on clinical trials diversity

30. september 2025 Rapporteret af 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 Clears Apple Watch Hypertension Detection

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.

FDA Approves New Schizophrenia Treatment

10. september 2025 Rapporteret af AI

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.

torsdag d. 1. januar 2026, 08.26