News about "Amgen"

Biocon Biologics, Amgen Settle Patent Dispute, Paving Way for US Launch of Denosumab Biosimilars

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 239

Amgen Commits USD 650 Million to USA Manufacturing Expansion Ahead of Tariff Pressure

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 123

Aurobindo's Subsidiary CuraTeQ Biologics Completes Phase 3 Clinical Study for Denosumab Biosimilar

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 191

Amgen and Kyowa Kirin Report Phase-III Results for Rocatinlimab in Atopic Dermatitis

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 106

Four Drugs in Race for First Bispecific ADC Approval: GlobalData

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 153

FDA Drug Approvals Fall in 2024, But Small Pharma Fuels Innovation Surge

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 255

UPLIZNA Becomes First and Only FDA-Approved Therapy for IGG4-Related Disease

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 263

FDA Approves Amgen's IMDELLTRA for Advanced Small Cell Lung Cancer

FDA Approves Amgen's IMDELLTRA for Advanced Small Cell Lung Cancer

The approval is based on the encouraging response rate and duration of response (DoR) observed in clinical studies, under the FDA's accelerated approval pathway.

Amgen | 17/05/2024 | By Abha 541


 

 

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