STAT+: Pharmalittle: We’re reading about a puzzling FDA rejection, a Lilly weight loss pill, and more

STAT News · Feb 26, 2026 · Collected from RSS

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By Ed SilvermanFeb. 26, 2026 Pharmalot Columnist, Senior Writer Top of the morning to you. Clear, blue skies and tolerable temperatures are enveloping the Pharmalot campus this morning, where the official mascots are snoozing here and there after hunting for breakfast and keeping neighbors at bay. As for us, we are as busy as ever with a growing to-do list filled with meetings, phone calls, and what-not. No doubt, you can relate. So time to get cracking. Please join us as we reach for yet another cup of stimulation — our choice today is hazelnut almond. Meanwhile, may we present you with a few tidbits to help you get started. Have a smashing day and remember to send us interesting tidbits that you come across. … An experimental therapy for a rare blood cancer was on the path toward approval by the U.S. Food and Drug Administration last year — with internal reviewers recommending it be cleared — before the agency rejected the drug last month, STAT reports. The cell therapy, being developed by Atara Biotherapeutics and Pierre Fabre Pharmaceuticals, is intended to treat a type of cancer that can occur following a stem cell or organ transplant. The condition afflicts approximately 500 patients in the U.S. each year and leaves them with weeks or months to live. The decision on the drug, called Ebvallo, marked one of a series of FDA rejections of rare disease therapies in recent months, suggesting the agency is setting a higher bar for approval of the medicines, even as FDA Commissioner Marty Makary and aides state repeatedly that regulatory flexibility to speed the approval of drugs for rare diseases is a priority for the agency. Eli Lilly’s oral GLP-1 orforglipron was more effective than Novo Nordisk’s recently launched Wegovy pill in a head-to-head diabetes trial, but likely won’t answer the question of which is better, Pharmaphorum tells us. The results of the trial showed the pill scored higher on various weight loss and glucose control measures than oral Wegovy across a range of doses for both drugs. However, the daily Wegovy doses selected for the trial — 7 milligrams and 14 milligrams — are relatively modest, and lower than the maximum 25 milligram allowable under the drug’s label as an obesity treatment. Higher doses of oral Wegovy have been shown to achieve greater glucose control in prior studies and are expected to be included in filings to expand its label to include type 2 diabetes. Meanwhile, there are differences in side effects between the two drugs that could also have an impact on their take-up — assuming, of course, that orforglipron is approved for marketing. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe