The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
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 ...
Replacing animal testing with alternate methodologies in preclinical drug trials holds potential for the development of ...
In a landmark decision poised to revolutionize drug development, the U.S. Food and Drug Administration (FDA) has announced a new initiative to significantly reduce, refine, and replace animal testing ...
The U.S. Food and Drug Administration will award up to $50 million over five years to the University of North Carolina at Chapel Hill and Duke University to establish the Research Triangle Center of ...
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 ...
The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit requests to take part in the program. Companies are limited to one submission ...
FDA orphan designation for zenocutuzumab‑zbco targets NRG1 fusion–positive advanced cholangiocarcinoma, a small molecular subset within an aggressive malignancy with <15% five-year survival. Orphan ...
The West Virginia House of Delegates and Mississippi House of Representatives have both approved bills to support research in ...
The FDA has granted breakthrough therapy designation to Novartis’ ianalumab for Sjögren’s disease, according to a press release from the manufacturer.In its statement, Novartis said it plans to submit ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results