Drugs

Lilly’s Oral Obesity Drug Foundayo Wins Approval

FDA has approved Eli Lilly’s Foundayo (orforglipron), a once-daily oral treatment for adults with obesity or those who are overweight with related health conditions. The approval marks Lilly’s second authorized obesity medicine, joining weekly injectable Zepbound (tirzepatide), and introduces a pill-based alternative in a market largely dominated by injectable GLP-1 therapies. An agency release notes that this was the fifth approval and the first new molecular entity under the Commissioner's National Priority Voucher pilot program. The approval action was made 50 days after filing and 294 days before the application’s user fee review target date of 1/20/2027, it says.

Foundayo is a small-molecule, non-peptide GLP-1 receptor agonist designed to promote weight loss when used alongside diet and exercise. Approval was based on data from the Phase 3 ATTAIN program. In the ATTAIN-1 trial, patients who remained on the highest dose of Foundayo lost an average of 27.3 pounds, or 12.4% of body weight, compared with 2.2 pounds (0.9%) for placebo, Lilly says. Across all participants, regardless of completion, average weight loss reached 11.1% versus 2.1% with placebo. The drug also improved several cardiovascular risk markers, including cholesterol levels, triglycerides, waist circumference, and blood pressure, it adds.

The approval comes as demand for weight-loss medications continues to surge, with drugmakers racing to develop more convenient and scalable options. Unlike injectable therapies, Foundayo’s oral formulation may lower barriers to initiation and long-term adherence. Foundayo will face stiff competition from Novo Nordisk’s once-daily pill version of Wegovy (semaglutide), which was approved by FDA in late December.

However, the drug carries safety warnings consistent with the GLP-1 class, according to the company. Labeling includes a risk of thyroid tumors, including cancer, and common side effects such as nausea, diarrhea, constipation, and abdominal discomfort. It also notes the drug is not recommended for use with other GLP-1 therapies and has not been established as safe or effective in children.

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome