The US FDA approved 46 new drugs in 2025, despite a tumultuous year at the regulatory agency.

Bayer's Hyrnuo, a tyrosine kinase inhibitor, was approved for advanced NSCLC with HER2 mutations, contingent on confirmatory trials for clinical benefit verification. Regeneron's Eylea HD, approved ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.

Insmed (NASDAQ: INSM) is breathing easier since the FDA has approved the company’s Brinsupri™ (brensocatib 10 mg and 25 mg tablets) as the first drug authorized to treat non-cystic fibrosis ...