The Prescription Drug User Fee Act target action date for the NDA is scheduled for 24 July 2026.
Key highlights from the Type C FDA meeting include: FDA confirms the approach that the proposed primary endpoint of the ...
The MarketWatch News Department was not involved in the creation of this content.-- Centanafadine is an investigational compound for the treatment of ADHD in children, adolescents ...
FDA debuts domestic pharma supply chain plan to streamline facility assessments and accelerate U.S. pharmaceutical manufacturing readiness.
SHANGHAI, Jan 27 (Reuters) - China's medicine regulator has ordered a halt to the import, sale and usage of a drug used to ...
SHANGHAI, Jan 27 (Reuters) - German drugmaker Boehringer Ingelheim will license an experimental inflammatory bowel disease ...
Insilico Medicine and Qilu Pharmaceutical Group announced a strategic collaboration to jointly develop small-molecule inhibitors for cardiometabolic diseases, combining Insilico’s generative AI–driven ...
For much of the past decade, drug shortages in the United States were treated as episodic disruptions. In 2024, that framing ...