Thomas Fuller | SOPA Images | Lightrocket | Getty Images UniQure plans to seek FDA approval of its experimental gene therapy for Huntington’s disease, the company said Wednesday, months after previous agency leaders criticized the evidence backing the application. UniQure said the FDA in a recent meeting communicated that a three-year analysis from a Phase…
Martin Makary, commissioner of the Food and Drug Administration (FDA), during a news conference at the US Food and Drug Administration headquarters in Silver Spring, Maryland, US, on Tuesday, April 28, 2026. Valerie Plesch | Bloomberg | Getty Images U.S. Food and Drug Administration Commissioner Marty Makary defended himself in a CNBC interview aired Tuesday…
FILE PHOTO: Psilocybin or “magic mushrooms” are seen in an undated photo provided by the U.S. Drug Enforcement Agency (DEA) in Washington, U.S. May 7, 2019. DEA | Reuters The U.S. Food and Drug Administration on Friday announced a series of measures aimed at accelerating the development of psychedelic treatments for serious mental illness. That…
Investors are concerned about the fates of multiple experimental drugs for hard-to-treat diseases following a string of recent rejections from the U.S. Food and Drug Administration. The FDA in the past year has denied or discouraged the applications of at least eight drugs, according to RTW Investments, including a gene therapy for Huntington’s disease from…
The logo for the Food and Drug Administration is seen ahead of a news conference at the Health and Human Services Headquarters in Washington, DC on April 22, 2025. Nathan Posner | Anadolu | Getty Images A key U.S. Food and Drug Administration official who oversees vaccines and biotech treatments will step down from the…
SINGAPORE — Sentosa Island boasts the luxury, five-star Ora and Michael hotels, with palm-tree-lined pools, lobbies flanked with luxury stores, and a casino that adjoins both hotels and buzzes with gamblers. The Singapore resort is also where a group of federal employees from the U.S. Food and Drug Administration were sent for a work trip…
Douglas Ingram, president and chief executive officer of Sarepta Therapeutics Inc., during the Forbes Healthcare Summit in New York, US, on Tuesday, Dec. 5, 2023. Michael Nagle | Bloomberg | Getty Images Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy treatment appeared at risk. The…
The Food and Drug Administration will consider drug affordability when granting companies new vouchers that speed up approvals of some treatments, the agency’s Commissioner Marty Makary told CNBC on Friday. The FDA in June announced a national priority voucher plan that aims to cut drug review times to one-to-two months for companies it says are…
