FDA News

The Women’s Sexual Health Test (Visby Medical) delivers results in approximately 30 minutes using a vaginal swab.

The FDA granted fast track designation to Sanofi’s chlamydia vaccine candidate today, aiming to prevent infections and address an unmet public health need.

Gepotidacin is the first new oral antibiotic for uncomplicated urinary tract infections in 30 years, offering an alternative amid rising antibiotic resistance.

Your daily dose of the clinical news you may have missed.

Your daily dose of the clinical news you may have missed.

Omlyclo is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria.

The FDA set the Prescription Drug User Fee Act (PDUFA) date for December 16, 2025.

The FDA approval of neffy 1 mg follows the earlier approval of the 5 mg version in August 2024.

The first low-dose rivaroxaban generic tablets to be FDA approved lead a field crowded with applications for formulations of all the higher doses.

Your daily dose of the clinical news you may have missed.