The Daily Signal16h
FDA’s ‘Drug Safety Priorities’ Working Group Politicized Under Biden Administration
America’s FDA leadership has been making decisions based on ideology, not drug safety. It's time for a change of priorities.
gastroenterologyadvisor20h
American Cancer Society Calls for Restoration of Key CDC, FDA Data
The withholding and removal of data on the CDC and FDA websites could negatively affect cancer research, American Cancer Society warns.
STAT20h
Tumult in FDA’s medical device center; one CEO speaks out on NIH cuts
The cuts hit the FDA’s medical device center particularly hard, impacting product reviewers and researchers of AI-enabled medical technology. Notably, the center has a strained relationship with one ...
Contract Pharma20h
FDA Grants Priority Review to Boehringer Ingelheim’s NDA for Zongertinib
The U.S. Food and Drug Administration (FDA) has granted Priority Review to Boehringer Ingelheim’s new drug application for zongertinib (BI 1810631) for the treatment of adult patients with ...
pna22h
FDA, Japan's PMDA strengthen ties to accelerate regulation processes
The Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) met on Tuesday to optimize the facilitated review pathway (FRP) to expedite access to essential ...