WASHINGTON — The Food and Drug Administration is struggling to select a new head of its drug center after the sudden and chaotic exit of the previous director, George Tidmarsh. Richard Pazdur, the director of the FDA’s Oncology Center for Excellence, was approached about the job and turned it down, two sources told STAT. The Pink…
FDA Approves Lumateperone for Major Depressive Disorder We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok Source link
FDA Approves Linaclotide as First Treatment for IBS-C in Children Aged 7 and Older We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok Source link
The FDA occupies a unique and pivotal role: as regulator of new medicines, it must ensure therapies are safe and effective—but also that they reach patients in need without undue delay. Today, the agency is under growing scrutiny. Recent leadership upheaval and regulatory reversals—especially a sharp turn in the case of uniQure N.V.’s gene-therapy for…
The second batch of Commissioner’s national priority vouchers (CNPVs) has been published by the FDA, and includes new GLP-1 agonists for weight-loss from Eli Lilly and Novo Nordisk and drugs for cancer and rare diseases. The scheme – first announced earlier this year – provides a fast track for medicines that are deemed to be…
WASHINGTON — The Food and Drug Administration on Thursday announced the second batch of companies being granted a “Commissioner’s National Priority Voucher,” a ticket to speedier reviews of drug candidates aligned with U.S. priorities. The announcement came as the Trump administration unveiled agreements with Eli Lilly and Novo Nordisk to reduce the prices of popular weight…
The weight loss drug Gold Rush has entered a new phase. As major telehealth companies scramble to maintain their grip on the lucrative GLP-1 market, they’ve found a creative workaround: “microdosing.” Noom, Found, and Hims & Hers have all recently launched programs offering lower doses of semaglutide and tirzepatide, marketing them as gentler alternatives with…
FDA Approves Oral Semaglutide for Cardiovascular Risk Reduction in Type 2 Diabetes We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok Source link
FDA Approves Epioxa for treatment of Keratoconus We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok Source link
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. The administration is making a lot of promises about TrumpRx. I invite help sorting out the difference between that website and others that already…