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- FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 DiabetesOn June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ag…fda press · 1mo ago↗ source
- CMS seeks to close Medicare negotiation 'loophole'CMS has proposed a policy change that clarifies its stance on how products are grouped together for Medicare negotiations. Under the Inflation Reduction Act, biologics become eligible for Medicare…Endpoints · 1mo ago↗ source
- FDA plans to keep Makary priorities on trials, China, deputy saysPHILADELPHIA – Following the recent departures of FDA Commissioner Marty Makary and both of his center directors for drugs and biologics, the Trump administration will continue pushing their priori…