FDA News

FDA Approves Gepotidacin (Blujepa) for Treatment of Uncomplicated UTIs

March 25, 2025

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

Omlyclo Gains FDA Approval as Interchangeable Omalizumab Biosimilar: Daily Dose

March 24, 2025

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

FDA Approves Neffy 1 mg Epinephrine Nasal Spray: Daily Dose

March 13, 2025

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

FDA Approves Omlyclo as First Interchangeable Omalizumab Biosimilar

March 10, 2025

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.

FDA Accepts Depemokimab BLA for Asthma and Chronic Rhinosinusitis with Nasal Polyps

March 06, 2025

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

FDA Approves Neffy 1 mg Epinephrine Nasal Spray, Only Needle-Free Treatment for Patients Weighing Less Than 30 kg

March 06, 2025

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

First Rivaroxaban Generics (2.5 mg) Get FDA Approval

March 05, 2025

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

FDA Approves First Rapid-Acting Insulin Biosimilar for Diabetes: Daily Dose

March 03, 2025

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

FDA Clears Google Pixel Watch 3 Loss of Pulse Detection Feature

February 28, 2025

The Loss of Pulse Detection feature will begin rolling out in the US late next month.

FDA Greenlights New Wearable Treatment for Parkinson Disease: Daily Dose

February 28, 2025

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