"FDA and EMA release collaborative AI framework for drug development" was originally created and published by Clinical Trials ...

FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...

AB-1009 is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. For more information, ...

In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...

Food and Drug Administration commissioner Marty Makary's flagship effort to overhaul how the agency reviews drugs is facing intensifying scrutiny from Congress and the medical establishment over ...

The FDA says it is hiring more than 1,000 new employees and rolling out a pilot communication program in an effort to speed up the review of new drugs. “FDA announced over 40 job announcements for ...

Biosplice Therapeutics, Inc. ("Biosplice"), a clinical-stage biotechnology company pioneering first-in-class therapeutics based on small-molecule inhibition of CLK/DYRK kinases, announced today that ...