The FDA has approved Transcranial Magnetic Stimulation (TMS), a non-drug, magnetic pulse device, for use in teens as young as ...

FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, while safe, ...

The FDA approved an intravenous (IV) formulation of fosfomycin (Contepo) to treat adults with complicated urinary tract ...

The FDA has approved Rybelsus® to reduce the risk of MACE in adults with T2DM who are at high risk for these events.

T he FDA approved doxecitine and doxribtimine powder (Kygevvi) for thymidine kinase 2 deficiency (TK2d), an ultra-rare ...

UCB has scored an FDA approval for ultra-rare disease treatment Kygevvi, continuing the positive momentum for the Belgian ...

Treatments for asthma, chronic rhinosinusitis with nasal polyps, dyslipidemia, Cushing syndrome, gonorrhea, HSCT-associated thrombotic microangiopathy, marginal zone lymphoma, motion sickness, ...

After a three-month delay, the FDA has now rejected an approval request based on the RWE. According to Biohaven, the FDA’s complete response letter “cited issues that can be inherent to real-world ...

In October 2025, the U.S. Food and Drug Administration (FDA) granted approval to multiple new cancer therapies and supportive ...

DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of ...

The FDA plans to eliminate comparative clinical study requirements that currently add $24 million and up to eight years to ...

The head of the U.S. Food and Drug Administration’s drug division, Dr. George F. Tidmarsh, resigned on November 2, 2025, one ...