STAT+: Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more
Sanofi asked the FDA to pull teplizumab out of a speedy review voucher program after a political appointee disagreed with staff over its approval
STAT PlusNewsletterPharmalot Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more Interpol seized 6.42 million doses of unapproved and counterfeit drugs from 90 countries Manage alerts for this article Email this article Share this article By Ed SilvermanMay 7, 2026 Pharmalot Columnist, Senior Writer Ed Silverman[email protected]Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter. Top of the morning to you, and a fine one it is.
Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Jack Daniel’s.
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Meanwhile, here are a few items of interest. Hope you have a smashing day and conquer the world. And of course, do stay in touch.
We appreciate feedback, criticism and tips. … Sanofi asked the U.S. Food and Drug Administration to pull its type 1 diabetes drug, teplizumab, out of FDA Commissioner Marty Makary’s new speedy review program, STAT reports.
The move comes after acting Center for Drug Evaluation and Research Director Tracy Beth Høeg disagreed with a staff decision to approve the drug. The agency missed its April 21 goal date to deliver a decision to Sanofi. Such decisions are typically made by career scientists.
It is rare for a center director to become involved in scientific review of a single drug, and particularly a political appointee like Høeg. Makary recently said that he stands behind review teams, and that “disaster” occurs whenever political leaders overrule scientific staff. Advertisement An experimental drug from Revolution Medicines that nearly doubled survival time for patients with advanced pancreas cancer in clinical trials comes with a high rate of mostly low-grade side effects, Reuters tells us.
A report by researchers from a first-in-human trial of daraxonrasib is the first peer-reviewed paper to show safety data for what analysts say could become the next standard of care for previously treated metastatic pancreatic cancer. Among the 168 patients with previously treated pancreatic ductal adenocarcinoma who received daraxonrasib in the early trial, treatment-related adverse side effects of any grade occurred in 96%, while severe or life-threatening events were reported in 30%. STAT+ Exclusive Story Already have an account?
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