FDA Approves Celltrion’s Xolair Biosimilar Omlyclo for Multiple Indications
March 10th 2025Omlyclo, a biosimilar to Xolair, is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergies, and chronic spontaneous urticaria.
Fast-Tracking Innovation: The Role of Regulatory Designations in DB-OTO’s Development
March 10th 2025Jonathon Whitton, AuD, PhD, VP, auditory global program head, Regeneron, discusses how key regulatory designations, such as the FDA's Regenerative Medicine Advanced Therapy designation, facilitate accelerated development and commercialization of DB-OTO through increased collaboration with regulators.
Ebglyss Demonstrates Sustained Efficacy in Moderate-to-Severe Atopic Dermatitis
March 7th 2025Clinical trial results found that a majority of patients with atopic dermatitis who were treated with Ebgylss achieved complete or near complete skin clearance at three years on a single monthly maintenance dose.