FDA
FDA nominee Heidi Overton hearing: Vaccines, vapes, and China
WASHINGTON — Heidi Overton, President Trump’s nominee to lead the Food and Drug Administration, was grilled by senators on hot button topics like China, vaccines, and abortion access in her hearing before the committee that will decide whether to send her nomination for a vote of the full Senate. Throughout the two-hour hearing, Overton, a […]
Radiopharma companies merge after one receives surprise FDA rejection
Allison covers what hot startups are getting up to, and who’s financing them. She is also co-host of the weekly biotech podcast, “The Readout Loud.” You can reach Allison on Signal at AllisonDeAngelis.01. ITM Isotope Technologies Munich SE and Telix Pharmaceuticals, two leading companies in the burgeoning radiopharmaceuticals field, are merging in a deal worth […]
STAT+: FDA names acting heads of drug and vaccine centers to permanent roles
WASHINGTON — 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. Three of the officials are serving in an acting capacity, and will take the same roles permanently, the administration said. They are Michael Davis, […]
FDA CBER, ACA grant impact, cyclosporosis: morning rounds
Get your daily dose of health and medicine every weekday with STAT’s free Morning Rounds newsletter. Register here. Good morning. I dedicate the first article of today’s newsletter to a friend who suffers from what she suspects is cyclosporosis. Please feel free to forward this email to your friends who need information but are afraid […]
FDA, Covid vaccine list, football brain health: morning rounds
Get your daily dose of health and medicine every weekday with STAT’s free Morning Rounds newsletter. Register here. Hello everyone. Now that we’ve all narrowly survived a non-World Cup day at work, we can finally return to our new normal this afternoon for France 3-1 Morocco. A father’s quest to heal his daughter Matt Wilsey […]
FDA and Zyn, Anthropic Claude Science, alcohol consumption: Morning Rounds
Get your daily dose of health and medicine every weekday with STAT’s free Morning Rounds newsletter. Register here. Hi everyone, Sarah is replacing Theresa today. If you’re on the East Coast, how are you preparing for the upcoming heat wave? Send popsicle tips and recipes to [email protected]. How the alcohol industry is putting its politics […]
FDA briefs lawmakers on food safety priorities
WASHINGTON — Food and Drug Administration officials briefed senators on the agency’s food policy plans for 2026, according to a person familiar with the meeting. The agency plans to focus on infant formula safety, updating food labels, defining ultra-processed foods, expanding inspections of food processing plants and strengthening seafood safety programs, according to a document […]
5 lessons from Vinay Prasad’s turbulent tenure at the FDA
Vinay Prasad, head of the Food and Drug Administration, self-destructed last week. The FDA announced Friday evening that he would resign next month after a series of controversial decisions on vaccines and gene therapies. His unique ability to attract criticism – even when his bosses, including the president, wanted him to keep his head down […]
FDA declares Novo Nordisk drug manufacturing plant non-compliant
A troubled contract manufacturing plant in Indiana recently acquired by Novo Nordisk is considered noncompliant with Food and Drug Administration standards, a serious designation that could further delay approval of drugs made at the facility, including some from Scholar Rock and Regeneron Pharmaceuticals. STAT previously reported that an FDA inspection of the plant over the […]
The unusual criticism of the FDA regulator to therapy is stirring Wall Street
Adam Feuerstein is a main writer and biotechnology columnist, reporting on the crossroads of drug development, business, Wall Street and biotechnology. He is also co-host of the weekly biotech podcast The Readout Loud and author of the Biotech dashboard of the Adam newsletter. You can reach Adam on the signal to stataf.54. George Tidmarsh, the […]