FDA
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 […]
Combien la FDA peut-il vraiment freiner les publicités pharmaceutiques?
Cet article est apparu pour la première fois dans la newsletter de votre épidémiologiste local.Les publicités pharmaceutiques aux États-Unis sont ennuyeuses. Absurde. Et presque uniquement américain. En fait, seul un autre pays à revenu élevé dans le monde entier – la Nouvelle-Zélande – permet aux compagnies pharmaceutiques d’ordonnance de faire de la publicité directement aux […]
Vinay Prasad returns to the FDA, weeks after her evidence
Washington – Vinay Prasad returns to the Food and Drug Administration to resume its supervising role the vaccine, gene therapy and the regulation of blood products. “At the request of the FDA, Dr. Vinay Prasad takes over the leadership of the Center for Biologics Evaluation and Research,” the health and social services spokesman Andrew Nixon […]
7-oh repression of the FDA sons on Kratom
The Trump administration moved Tuesday to add 7-oh, a psychoactive compound derived from the Kratom factory, on the calendar of controlled substances. The movement specifically targets products with high levels of 7-OH, which occurs naturally in the Kratom in quantities of trace. But the Food and Drug Administration stressed in an advertisement that the application […]
SAREPTA is resistant to the FDA on elements, the agency chooses the best drug regulator | Stat
Hello everyone, it’s Jason Mast, filling for Ed. Today, I am at the New York office in Pharmalittle, sipping a Bread’s Bakery coffee, which serves the best Babka in Manhattan. (The best babka in the country, for those who wonder, is that of my mother. She does not take orders, but if you are really, […]
The FDA approves the Novavax coverage vaccine after delay
Helen Branswell covers questions largely linked to infectious diseases, including epidemics, preparation, research and the development of vaccines. Follow it on Mastodon and Bluesky. You can reach Helen on signal at Hbranswell.01. The Food and Drug Administration finally approved the COVVI-19 Novavax vaccine, but in doing so, this imposed restrictions on its two competitors on […]
First home testing kit for cervical cancer approved by the FDA
Washington – American regulators approved the first cervical cancer test kit which allows women to recover their own sample at home before shipping it in a laboratory, according to a medical devices. Teal Health said on Friday that Food and Drug Administration approved its Turacine wand for domestic use, offering a new way of collecting […]