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News about "Jay Bradner"
US FDA Approves Uplizna for Adults with Generalised Myasthenia Gravis
The US FDA has approved Uplizna for adults with generalised myasthenia gravis, marking a significant advancement as the first and only CD19-targeted B-cell therapy for both anti-AChR and anti-MuSK antibody–positive patients, offering durable disease control with just twice-yearly dosing.
Jay Bradner | 12/12/2025 | By Akanki
Amgen and Kyowa Kirin Report Phase-III Results for Rocatinlimab in Atopic Dermatitis
Amgen and Kyowa Kirin report top-line results from ongoing ASCEND study evaluating Rocatinlimab’s long-term safety and efficacy in adults with moderate to severe Atopic Dermatitis following prior ROCKET trials.
Jay Bradner | 09/09/2025 | By Dineshwori | 143
Amgen Reports Positive Interim Results for IMDELLTRA in Small Cell Lung Cancer Study
IMDELLTRA demonstrated statistically significant and clinically meaningful improvement in overall survival compared to local standard-of-care chemotherapy.
Jay Bradner | 14/04/2025 | By Abha | 368
UPLIZNA Becomes First and Only FDA-Approved Therapy for IGG4-Related Disease
The FDA granted Breakthrough Therapy Designation to UPLIZNA for the treatment of IgG4-RD, recognising the high unmet medical need in this serious condition and the medicine's potential to benefit patients.
Jay Bradner | 05/04/2025 | By Abha | 343
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