RAPS

New FDA Document Clarifies IND Process for Drugs, Biologics and Biosimilars

A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...
Health AffairsOpinion

Refining FDA’s Plausible Mechanism Framework, Part 1: Understanding The Draft Guidance And Clarifying The Framework’s Scope

This is part one of a two-part article offering proposals to improve the FDA’s guidance to implement a new approval framework ...
Morningstar

GNTbm's self-developed anti-cancer new drug GNTbm-38 has obtained IND approval from the U.S. FDA for Phase I clinical trials

TAIPEI, March 5, 2026 /PRNewswire/ -- Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm) (stock code: 7427) announced that its independently developed novel epigenetic immunoactivator ...