FDA News and Regulatory Updates

Dupilumab (Dupixent) is the first new targeted therapy for CSU in over a decade.

Review 10 new FDA-approved drugs that may soon find a place in your prescribing routine, including new treatments for UTIs, acute pain, and more.

CT-132 is a 12-week app-based intervention that uses validated behavioral techniques to modulate labile brain circuitry involved in migraine, according to Click Therapeutics.

The FDA and Novo Nordisk are urging health care professionals to check semaglutide (Ozempic) injection 1 mg lot PAR0362 with serials starting 51746517.

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

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

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.

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.

The Metrix COVID/Flu molecular test detects and differentiates SARS-CoV-2, influenza A, and influenza B in approximately 20 minutes.

These label changes to Sublocade from Indivior mark a significant advancement in the management of moderate to severe opioid use disorder.

The clearance enables Alphyn to initiate global phase 2b clinical trials, which are anticipated to begin in the first quarter of 2025.

Merilog joins two long-acting insulin biosimilar products approved in 2021, bringing the total to three insulin biosimilars available in the United States.