New products from Rx to OTC
FDA Approves Dupilumab for Treatment of Chronic Spontaneous Urticaria
The approval is based on 2 phase 3 studies demonstrating reductions in itch severity and urticaria activity as a composite of itch and hives at 24 weeks.
Episode 8: Stay in Sync with Innovations in Medication Decision Support
Episode 8 of Over the Counter discusses the new and exciting modernizations in the medication decision support space.
FDA Grants Yuflyma Interchangeability Designation for Humira
The FDA approved adalimumab-aaty in May 2023 for 8 indications, including rheumatoid arthritis, psoriatic arthritis, Crohn disease, ulcerative colitis, and plaque psoriasis.
FDA Approves Subcutaneous Vyvgart Hytrulo for Generalized Myasthenia Gravis
The drug is also approved for adults with chronic inflammatory demyelinating polyneuropathy.
FDA Grants Fast Track Designation for Potential Bird Flu Vaccine
The designation addresses the unmet need for prevention of H5N1, which remains a global health risk, and a phase 1 trial of the vaccine was initiated in November 2024.
FDA Approves Generic Liraglutide for Type 2 Diabetes
As of April 2, 2025, liraglutide remained in shortage, with the drug first entering the FDA database on July 18, 2023.
