A new analysis of drug trials used to approve medicines in the United States shows how far modern medicine still has to go to ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
A clear breakdown of the process, showing each step in detail to help viewers understand techniques, methods, and the reasoning behind every action. Is Putin next? Zelensky and the Kremlin react to ...
A new project seeking to transform the drug delivery process and take projects out of “the valley of death” between aspiration and accomplishment is getting help from La Jolla-based medical research ...
In April 2025, the U.S. Food and Drug Administration (FDA) released its Roadmap to Reducing Animal Testing in Preclinical Safety Studies—a landmark initiative that lays out a plan to make animal ...
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former ...
Please provide your email address to receive an email when new articles are posted on . AIM-MASH AI Assist is the first AI drug development tool to be qualified by the FDA. The tool is designed to ...
Dec 8 (Reuters) - The U.S. Food and Drug Administration has qualified the first artificial intelligence tool designed to help doctors assess a severe form of fatty liver disease in drug trials, the ...
The FDA has qualified its first artificial intelligence tool to help drug developers evaluate fatty liver disease in their clinical trials. The agency gave a green light to the AI-Based Histologic ...
In our latest IPWatchdog Unleashed podcast, I spoke with Rob Sahr, shareholder at Wolf Greenfield and co-chair of our 2025 Life Sciences Masters™ program. Our conversation zeroed in on a hard truth ...
The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
FRANKFURT, Germany--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, will showcase its latest flexible solutions to help boost efficiency and scale in ...