❌

Normal view

  • βœ‡STAT
  • STAT+: FDA names acting heads of drug and vaccine centers to permanent roles Margaret Manto
    WASHINGTON β€” The Trump administration permanently filled four key leadership roles at the Food and Drug Administration on Tuesday, after it nominated Heidi Overton to lead the agency late last month.Β  Three of the officials are serving in an acting capacity, and will take the same roles permanently, the administration said. They are Michael Davis, a psychiatrist who will be director of the Center for Drug Evaluation and Research; former Merck official Karim Mikhail, who will be director of th
     

STAT+: FDA names acting heads of drug and vaccine centers to permanent roles

9 September 2026 at 05:15

WASHINGTON β€” The Trump administration permanently filled four key leadership roles at the Food and Drug Administration on Tuesday, after it nominated Heidi Overton to lead the agency late last month.Β 

Three of the officials are serving in an acting capacity, and will take the same roles permanently, the administration said. They are Michael Davis, a psychiatrist who will be director of the Center for Drug Evaluation and Research; former Merck official Karim Mikhail, who will be director of the Center for Biologics Evaluation and Research; and Bret Koplow, an attorney who has been at the FDA since 2011 and will serve as director of the Center for Tobacco Products.Β 

The fourth appointee, Jared Seehafer, will serve as the FDA’s first deputy commissioner for technology and artificial intelligence. He joined the FDA as an adviser in 2025 after founding a life science software company and working in investment advising in biotech, according to his LinkedIn. Under the Trump administration, the agency has pushed its staff to use AI to speed up its review processes.Β 

Continue to STAT+ to read the full story…

Β© FDA

  • βœ‡STAT
  • STAT+: Replimune skin cancer drug that became FDA flashpoint is rejected again Jason Mast
    The Food and Drug Administration on Friday rejected β€” again β€” an experimental treatment for advanced skin cancer developed by Replimune Group.Β  Replimune’s treatment, an engineered virus designed to rev up the immune system against melanoma, has been a flashpoint in a simmering debate over shifting standards at the agency. The drug was initially rejected in July, just two months after Vinay Prasad was appointed the FDA’s head of biologics. As an academic oncologist, Prasad criticized regul
     

STAT+: Replimune skin cancer drug that became FDA flashpoint is rejected again

10 April 2026 at 23:23

The Food and Drug Administration on Friday rejected β€” again β€” an experimental treatment for advanced skin cancer developed by Replimune Group.Β 

Replimune’s treatment, an engineered virus designed to rev up the immune system against melanoma, has been a flashpoint in a simmering debate over shifting standards at the agency.

The drug was initially rejected in July, just two months after Vinay Prasad was appointed the FDA’s head of biologics. As an academic oncologist, Prasad criticized regulators for approving drugs with limited data, and the Replimune decision was viewed as a possible sign of the stricter stance he might take at the agency.

Continue to STAT+ to read the full story…

Β© Markus Schober and Elaine Fuchs, The Rockefeller University/NIH

  • βœ‡STAT
  • STAT+: Health insurers score major win with higher 2027 Medicare Advantage rates Bob Herman
    Companies that sell Medicare Advantage plans will receive a 2.5% pay bump on average in 2027, up significantly from what was proposed and a win for an industry that has experienced higher medical costs and has opposed nearly all reforms to the lucrative taxpayer-financed program. More importantly, the Trump administration scrapped a proposal that would have used more updated data in the payment process, ensuring that Medicare Advantage insurers retain billions of dollars. The finalized r
     

STAT+: Health insurers score major win with higher 2027 Medicare Advantage rates

7 April 2026 at 04:48

Companies that sell Medicare Advantage plans will receive a 2.5% pay bump on average in 2027, up significantly from what was proposed and a win for an industry that has experienced higher medical costs and has opposed nearly all reforms to the lucrative taxpayer-financed program.

More importantly, the Trump administration scrapped a proposal that would have used more updated data in the payment process, ensuring that Medicare Advantage insurers retain billions of dollars.

The finalized rate is estimated to add $13 billion in revenue next year for insurers, according to the Centers for Medicare and Medicaid Services. During trading after the markets closed, the stock prices of UnitedHealth Group, Humana, and CVS Health each climbed by more than 8%. Those companies are the three largest Medicare Advantage insurers, and together cover almost 60% of all people enrolled in the program.

Continue to STAT+ to read the full story…

Β© Pablo Martinez Monsivais/AP

❌