June 26, 2024
May 15, 2025
September 16, 2024
July 15, 2026
In a recent town hall meeting, Karim Mikhail told Food and Drug Administration staff that he was normal. “I am with you on planet Earth,” he said in June. “I understand very well what everybody is going through.” Typically, such an acknowledgment would be unremarkable. But Mikhail is acting director of the FDA’s Center for…
Read MoreJuly 14, 2026
Welcome to the Clinical Minds “Innovator Insights Corner,” where we’ll be sharing fascinating stories, perspectives, and predictions from the guests of “from Dreamers to Disruptors,” a podcast by Medidata exploring life sciences innovation and the visionaries behind it all. External Control Arms (ECAs) are emerging as a powerful new tool in cancer research. Harnessing the rich clinical…
Read MoreJuly 13, 2026
PROPOSAL PUSHBACK — Patient and scientific research groups are sounding the alarm on a White House proposal they say would politicize the grant funding process at the National Institutes of Health and undermine the nation’s standing as the global leader in biomedical research. The proposed rule so far has received more than 275,000 comments — which are due…
Read MoreJuly 1, 2026
Rep. Diana DeGette (D-Colo.) was defeated in the Democratic primary Tuesday, ending the legislative career of a politician who built bipartisan support for the most impactful FDA reforms of the last two decades. DeGette was the central figure in an informal alliance of patient advocacy groups, life sciences innovators, and government officials that pushed legislation…
Read MoreJune 18, 2026
UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed? Things don’t always go more smoothly when the boss is away, but that…
Read MoreJune 18, 2026
Rare disease leaders from the FDA’s drug and biologics centers and an interdisciplinary hub met for a candid “Town Hall” event at the Drug Information Association’s Global Annual Meeting on June 17. Here, AgencyIQ provides our takeaways, from cultural shifts to tactical advice. Rare diseases were a focal point at the Drug Information Association global…
Read MoreJune 17, 2026
U.S. drug companies are accelerating licensing deals with Chinese pharmaceutical companies to take advantage of China’s clinical trials system. The Trump administration is eyeing the trend warily. New bipartisan legislation would create a vast biological database primed for AI-driven drug research. French photonics quantum computing company Quandela gets tapped for the Defense Advanced Research Projects…
Read MoreJune 11, 2026
A Friends of Cancer Research white paper proposes statutory changes allowing different levels of biomarker evidence across drug development stages, as well as near-term steps for the FDA to make the qualification process more transparent, predictable and useful. Key Takeaways The FDA’s biomarker qualification program is a single, all-or-nothing determination out of step with evidence…
Read MoreJune 5, 2026
During a meeting with acting FDA Commissioner Kyle Diamantas and other agency officials, rare disease groups discussed whether advisory committees could examine broader scientific, regulatory and development issues affecting multiple diseases more often. Key Takeaways Rare disease groups urged senior FDA officials to modernize its approach to endpoints, biomarkers, trial design and evidence generation for…
Read MoreJune 5, 2026
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, the Trump administration is reviewing candidates for FDA commissioner, the agency is trying to repair relations with the rare…
Read More
