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News about "Amgen"
Sanofi and Novartis have separately entered into agreements with the US government to reduce medicine prices for American patients while reinforcing long-term commitments to US-based manufacturing, research and innovation, marking a coordinated push to balance affordability with sustained pharmaceutical investment.
Amgen | 22/12/2025 | By News Bureau
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.
Amgen | 12/12/2025 | By Akanki
Biocon Biologics Reaches Settlement with Amgen, Secures Market Entry Date for Denosumab Biosimilars
Biocon Biologics will introduce both its Denosumab biosimilars — Vevzuo and Evfraxy — in Europe beginning December 2, 2025. Other terms of the settlement with Amgen remain confidential.
Amgen | 02/12/2025 | By Dineshwori
Biocon Biologics, Amgen Settle Patent Dispute, Paving Way for US Launch of Denosumab Biosimilars
The agreement with Amgen enables Biocon Biologics to launch denosumab biosimilars Bosaya and Aukelso in the US from October 1, 2025.
Amgen | 01/10/2025 | By Dineshwori | 314
Amgen Commits USD 650 Million to USA Manufacturing Expansion Ahead of Tariff Pressure
Amgen has announced plans to invest USD 650 million in expanding its USA manufacturing network, particularly at its biologics facility in Juncos, Puerto Rico, integrating advanced technologies across its operations.
Amgen | 29/09/2025 | By Darshana | 143
Aurobindo's Subsidiary CuraTeQ Biologics Completes Phase 3 Clinical Study for Denosumab Biosimilar
CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has successfully completed a pivotal clinical study of its denosumab biosimilar, evaluated against Amgen’s Prolia in 446 women with postmenopausal osteoporosis.
Amgen | 19/09/2025 | By Dineshwori | 242
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.
Amgen | 09/09/2025 | By Dineshwori | 143
Four Drugs in Race for First Bispecific ADC Approval: GlobalData
With 21 global approvals, ADCs generated USD 13.6 billion in 2024. BsADCs represent further opportunities in this field, by leveraging bi-specific antibodies that simultaneously bind two distinct targets.
Amgen | 02/09/2025 | By Dineshwori | 199
FDA Drug Approvals Fall in 2024, But Small Pharma Fuels Innovation Surge
The US Food and Drug Administration (FDA) approved 127 innovator and biosimilar drugs in 2024, marking a decline from the 149 approvals recorded in 2023, according to a report by leading data and analytics firm GlobalData.
Amgen | 19/07/2025 | By Dineshwori | 380
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.
Amgen | 05/04/2025 | By Abha | 341
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