Tirzepatide beat semaglutide head to head. The trial has two caveats worth knowing

Tirzepatide beat semaglutide head to head. The trial has two caveats worth knowing

The question people ask most often about these two drugs — which one works better — has a direct answer, and has had one since July 2025. In SURMOUNT-5, a trial that gave 751 adults either tirzepatide or semaglutide and followed them for 72 weeks, tirzepatide produced an average weight reduction of 20.2% against semaglutide’s … Read more

FDA proposes to bar semaglutide, tirzepatide and liraglutide from the 503B bulks list

FDA proposes to bar semaglutide, tirzepatide and liraglutide from the 503B bulks list

The FDA proposed not to include semaglutide, tirzepatide and liraglutide on the 503B bulks list — the roster of substances outsourcing facilities may legally compound from bulk. The agency stated it had reviewed the nominations it received and did not find sufficient evidence of a clinical need for any of the three. If finalised, the … Read more

FDA says adding B12 does not stop a compounded semaglutide product being a copy

FDA says adding B12 does not stop a compounded semaglutide product being a copy

The FDA restated the conditions a compounded drug must meet to qualify for the section 503A and 503B exemptions, and addressed a practice common in compounded GLP-1 products directly. It said a product combining semaglutide with another active ingredient, giving vitamin B12 (cyanocobalamin) as its example, may still be considered essentially a copy of a … Read more

FDA warns 30 telehealth companies over compounded GLP-1 marketing

FDA warns 30 telehealth companies over compounded GLP-1 marketing

The FDA issued warning letters to 30 telehealth companies over false or misleading claims made about compounded GLP-1 products sold on their websites. It was the second wave of letters aimed at telehealth firms since the agency opened a broader campaign against misleading direct-to-consumer drug advertising in September 2025, and the largest single action against … Read more

More than 50 warning letters to GLP-1 compounders and manufacturers

More than 50 warning letters to GLP-1 compounders and manufacturers

The FDA issued over 50 warning letters to US and international companies compounding or manufacturing semaglutide and tirzepatide. The cited conduct centered on marketing compounded GLP-1s as “generic versions” of the approved drugs, or making direct comparative claims against them. Sources: FDA warning letter database · Wilson Sonsini analysis

FDA launches a “green list” import alert for GLP-1 ingredients

FDA launches a green list import alert for GLP-1 ingredients

The FDA established a “green list” import alert covering GLP-1 active pharmaceutical ingredients, intended to stop unverified foreign-sourced APIs from entering the US market. Ingredients from facilities the agency has inspected or evaluated, and which appear to meet its manufacturing standards, are listed; APIs from any other source become subject to detention without physical examination. … Read more