FDA launches a new effort to aggregate clinical trial data on kidney safety biomarkers, seeking pharmaceutical industry participation in a pilot progr...
FDA issues an early alert warning healthcare providers about a potentially high-risk defect affecting certain infant resuscitation systems manufacture...
PhRMA calls on FDA to provide clearer regulatory expectations for the use of digital health technologies in drug development, arguing that adoption ha...
FDA approves an expanded indication for Pfizer's hemophilia treatment Hympavzi (marstacimab-hncq), allowing its use in additional patient populations.
Stakeholders at FDA's public hearing on the Commissioners National Priority Voucher program urge the agency to temporarily suspend the initiative and ...
The House passes FDAs appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency.
FDA issues Xspray Pharma a complete response letter for the company's NDA for Nilopki, an improved formulation of nilotinib designed to compete with N...
FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlighting the growing use of the expedited pathway by ...
