FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...
A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...
New options for testing and treating some of the most common sexually transmitted diseases are becoming available.
The FDA has approved LIB Therapeutics’ LEROCHOL (lerodalcibep-liga) for the treatment of adults with elevated low-density lipoprotein cholesterol.
The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...
Although the year brought a steady stream of new treatments, tests, and cutting-edge science, experts worry about how ...
Database locks for studies on actinic keratosis (AK) and acne vulgaris achieved on January 5, 2026Data generated will support key regulatory ...
Data is from comprehensive review of hospital charges and all-payer claims over five years - - Preventable complications such as amputation and ...
The U.S. Food and Drug Administration has approved Myqorzo (aficamten) for the treatment of adults with symptomatic ...
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