FDA warns Indias Alembic Research Center that it failed to obtain informed consent for an in vivo bioequivalence study.
FDA awards Acadia Pharmaceuticals a Fast Track designation for remlifanserin, an investigational, highly selective, 5-HT2A receptor inverse agonist fo...
Two InnoDev Partners consultants urge industry to re-embrace the 505(b)(2) approval pathway in instances in which it can save drug development time an...
A Cureus Journal of Medical Science open-source editorial calls for a rebuilding of the U.S. scientific infrastructure as the only way to successfully...
The U.S. House of Representatives passes the FDA Modernization Act 3.0 (H.R. 2821), advancing bipartisan legislation intended to accelerate the adopti...
China approves more novel oncology drugs than the U.S. between 2020 and 2025, with its annual approval totals surpassing FDAs beginning in 2023, accor...
FDA accepts for priority review a Dyne Therapeutics BLA for zeleciment rostudirsen for treating individuals with Duchenne muscular dystrophy amenable ...
A Nevada businessman enters guilty plea to importing and distributing misbranded prescription erectile dysfunction drugs from India.
