The FDA has qualified AI-Based Histologic Measurement of MASH, or AIM-MASH AI Assist — the first AI drug development tool — ...
The FDA’s emerging framework represents more than a regulatory update; it is a paradigm shift toward human-relevant, ...
The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...
This effort to accelerate development can be clearly seen in how the agency is approaching biosimilars. In October 2025, the FDA issued a guidance update indicating that “switching” studies — a trial ...
SAN CARLOS, Calif. & WATERLOO, Ontario--(BUSINESS WIRE)--Onc.AI, a digital health company developing AI-driven oncology clinical management solutions using Deep Learning imaging AI, today announced ...
NetraMark Holdings Inc. (the 'Company” or 'NetraMark”) (CSE: AIAI) (OTCQB: AINMF) (Frankfurt: PF0) a premier artificial intelligence (AI) company that is transforming clinical trials with AI powered ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
A UCR study finds just 6% of clinical trials used to approve new drugs in the U.S. reflect the country’s racial and ethnic ...
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...
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