Tens of thousands of cholesterol medication bottles are being recalled nationwide due to manufacturing issues that could ...
GlobalData on MSN
FDA accepts Otsuka’s centanafadine application for ADHD treatment
The Prescription Drug User Fee Act target action date for the NDA is scheduled for 24 July 2026.
FDA debuts domestic pharma supply chain plan to streamline facility assessments and accelerate U.S. pharmaceutical manufacturing readiness.
Welcome to Fierce Pharma's regulatory tracker for the first half of 2026. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new ...
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
For much of the past decade, drug shortages in the United States were treated as episodic disruptions. In 2024, that framing ...
Legal and regulatory experts expect the FDA’s new DTC ad crackdown to face legal challenges. While the FDA’s letters to drugmakers were unprecedented, it may be difficult for the agency to actually ...
By Gnaneshwar Rajan and Sriparna Roy Jan 30 (Reuters) - Regeneron Pharmaceuticals' executives voiced confidence in its ...
SHANGHAI, Jan 27 (Reuters) - German drugmaker Boehringer Ingelheim will license an experimental inflammatory bowel disease ...
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