FDA News

Immunization in America: Highs and Lows by State
April 23, 2025

A quick look at the states ranking highest and lowest on metrics including influenza vaccination, tetanus vaccination, HPV vaccination, and more.

FDA Approves Dupilumab for Chronic Spontaneous Urticaria Uncontrolled by Antihistamines
April 18, 2025

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

10 Drugs Approved for Primary Care: Q1 2025
April 16, 2025

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.

FDA Grants First-in-Class Marketing Authorization for Digital Therapeutic in Episodic Migraine Prevention
April 16, 2025

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.

FDA, Novo Nordisk Investigating Counterfeit Semaglutide Injection in US Supply Chain
April 14, 2025

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

Guselkumab (Tremfya) Gains FDA Approval for Crohn Disease: Daily Dose
April 08, 2025

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

FDA Approves Gepotidacin for Treatment of Uncomplicated UTIs: Daily Dose
April 07, 2025

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

FDA Authorizes Marketing of First At-Home Test for Chlamydia, Gonorrhea, Trichomoniasis
March 31, 2025

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

Sanofi's Chlamydia Vaccine Granted FDA Fast Track Designation
March 26, 2025

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

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.