In a university lab, an AI system generated millions of novel molecules to fight drug-resistant infections. And they're ...
Following Afghan shooting case, Trump administration launches rigorous audit of immigration status for residents from nations ...
The next critical steps in the USFDA process involve a rigorous on-site evaluation: "visiting manufacturing facilities, ...
(hereinafter referred to as “Juventas”) announced that its independently developed CAR-T cell therapy product, Inaticabtagene Autoleucel (Ina-cel) (tradename: YORWIDATM), has received new drug ...
Powerful” new treatments for various types of cancer and neurodegenerative disorders, such as Alzheimer’s, Parkinson’s, and ...
In this Q&A, John Kirk, principal regulatory specialist at Veristat, explains how the FDA’s Commissioner’s National Priority ...
Khorakiwala said the Mumbai-based drugmaker is already laying groundwork for commercialization, with options ranging from ...
The hospital lobby has filed a lawsuit seeking to block the federal government’s 340B Rebate Model Pilot Program, which is ...
A constitutional challenge can be criminal or civil. It can be brought against any government action or legislation. Among ...
Researchers from CIIMAR and the University of Helsinki have discovered a new biochemical modification in natural ...
Discover how new U.S. Medicare drug price cuts impact major pharma stocks like Novo Nordisk and why sector resilience ...
December 1, 2025Sara Brenner, M.D., MPHPrincipal Deputy CommissionerU.S. Food and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993Submitted ElectronicallyRE: FDA-2025-N-4203 Request ...
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