STAT+: FDA approves Sanofi diabetes drug for children with stage 3 diabetes

STAT PlusPolitics FDA approves Sanofi diabetes drug for children with stage 3 diabetes Former CDER head Tracy Beth Høeg had disagreed with staff on approval Manage alerts for this article Email this article Share this article By Lizzy LawrenceJune 13, 2026 FDA Reporter Lizzy Lawrence[email protected]Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53. WASHINGTON — The Food and Drug Administration on Friday approved teplizumab, a type 1 diabetes drug developed by Sanofi, for children aged 8 and older with stage 3 diabetes. The drug was selected to go through a speedy review program launched last year by former FDA Commissioner Marty Makary, but the agency missed its goal date of April 21 to deliver a decision. Advertisement STAT previously reported that Sanofi asked to pull its drug out of the program after former top drug regulator Tracy Beth Høeg disagreed with a staff decision to approve the drug. It’s rare for a center director, and particularly a political appointee like Høeg, to get involved in individual scientific reviews. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In diabetes, FDA, Sanofi, STAT+ Submit a correction requestReprints Lizzy Lawrence FDA Reporter Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53. Newsletter The latest updates in federal health agencies, research institutes, and U.S. policy Recommended Politics June 12, 2026 STAT Plus: Trump administration revisits policy to close Medicare drug price negotiation loophole Business June 12, 2026 STAT Plus: At hospital finance conference, a call to end the friction that’s keeping costs high Advertisement STATus Report June 12, 2026 How a diabetes conference sparked a controversy Politics June 11, 2026 STAT Plus: Updated: Tracking RFK Jr.’s promises to remake health in America Politics June 11, 2026 RFK Jr. claims his calendar is publicly available. We’ve been trying to get it for a year Subscriber Picks