Posts

J&J wins first FDA label expansion for IMAAVY in rare blood disorder

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Ionis scores transformational FDA label expansion for Tryngolza

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Amgen’s Tavneos, facing liver injury scrutiny, gets label update in Japan as patient starts resume

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With Voxzogo under pressure, BioMarin touts trial win in label expansion bid

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Argenx's Vyvgart and Vyvgart Hytrulo Receive FDA Label Expansion for All Adult gMG Patients

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Insmed's Arikayce Achieves Phase 3 Success in MAC Lung Disease, Paving Way for Label Expansion and Potential Blockbuster Status

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Biopharma Bites: uniQure Pauses AMT-191 Dosing, GSK's Nucala Gets EU Nod, Gilead CAR-T Label Update

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FDA Requests Flu Vaccine Label Updates for Febrile Seizure Risk in Young Children

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FDA broadens label for Amgen’s Uplizna as it enters rare disease competition

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Recent Advances Shifting Perspectives in Cell Therapy (2025)

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Eli Lilly Touts 'Striking' Progression-Free Survival Results for Jaypirca in New Front-Line CLL Study

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Argenx's Vyvgart Shows Positive Phase 3 Results in Seronegative Myasthenia Gravis

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AbbVie and Genmab Move to Expand Use of T Cell Engager Epkinly Following Strong Phase III Results

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FDA Advisory Committee Unanimously Votes Against Expanding Pfizer's Prostate Cancer Drug Combo

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CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer's drug

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