FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.
The FDA will begin accepting applications Feb. 1 for its PreCheck pilot program, an initiative designed to strengthen the domestic pharmaceutical supply chain. The program aims to increase regulatory ...
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...
Jan 14 (Reuters) - The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe ...
The collaboration marks a turning point in AI-driven drug design and trial forecasting, de-risking the drug development ...
The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
A Type B meeting between the FDA and Plus Therapeutics offered clarity and direction for the next steps in development of ...
Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using artificial intelligence to transform the cost, pace, and timeline of oncology drug discovery and development, today ...
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