FDA News

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.

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

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

The FDA accepted the sNDA for risperidone (Uzedy) extended-release injectable suspension for the maintenance treatment of bipolar I disorder in adults.

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

Investigators reported that roflumilast cream 0.05% significantly reduced AD severity as early as Week 1, with a notable effect on pruritus seen in as little as 24 hours.