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 ...
March 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday issued a draft guidance to help companies reduce ...
The U.S. Food and Drug Administration is actively steering drug developers away from traditional animal studies and toward ...
Scientists at the University of Cambridge have developed a new way to alter complex drug molecules using light rather than ...
The U.S. Senate has a plan to improve drug development for rare disease patients. The exit of controversial CBER chief Vinay ...
Artificial intelligence is rapidly inventing new drugs for diseases from Parkinson's disease and antibiotic-resistant ...
The company was aiming for approval in the second half of 2028, paving the way for a market launch in 2029 Hangzhou-based biotech start-up MindRank has progressed to Phase 3 clinical trials for its ...