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The CMS has opened a request for applications to drug manufacturers and will accept responses through Jan

The application is based on a 64-week trial of 307 adults with obesity but without diabetes

Why Trust Post Wanted by the New York Post This article was written by Miska Salemann, New York Post Commerce Writer/Reporter

Gonda X, Dome P, Serafini G, Pompili M

e.g., LEADER, SUSTAIN-6, EXSCEL, HARMONY Outcomes, REWIND, ELIXA, AMPLITUDE-O, SELECT) and other large-scale clinical programs (e.g., PIONEER, AWARD, LEAD, SCALE, STEP)
As of May 2026, FDA has also proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List, after stating that it did not identify a clinical need for outsourcing facilities to compound these drugs from bulk substances when FDA-approved versions are available
