Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are reaching, as always, for a cuppa stimulation. Our choice today is peach ginger tumeric. Please feel free to join us. Meanwhile, here are a few items of interest to help you get started on your journey, which we hope is meaningful and productive. Best of luck, and do keep in touch. …
There is growing concern that the U.S. Food and Drug Administration, which under Commissioner Marty Makary has promised “radical transparency” via initiatives like releasing rejection letters, is actively shunning advisory committees that allow agency leaders, drug developers, patients, and physicians to speak their minds in public, STAT tells us. The agency held 14 advisory committee meetings in 2025, down from 38 in 2024 and 29 in 2023. The number of advisory committee meetings related to drugs decreased by 72% last year. The shift away from advisory committee meetings has coincided with a slide into regulatory uncertainty. The agency has seen tremendous turnover over the past year and political leaders have become unprecedentedly involved in scientific decisions.
The FDA is easing some requirements for drugmakers developing copycat versions of costly biologic medications in a bid to bring more competition to the market and lower costs, Bloomberg News reports. The agency plans to reduce the need for some studies that demonstrate the drugs, called biosimilars, are equivalent to the brand-name medications on which they are modeled. The FDA, which estimates the change could shave $20 million from the cost of developing a new biosimilar drug, expects to issue draft guidance as soon as Monday. The policy is part of a broader strategy to make it easier for companies to get biosimilar drugs approved. U.S. policymakers have long seen biosimilars as a tool to lower drug costs. The U.S. lags behind the European Union in the number of biosimilars approved.Continue to STAT+ to read the full story…