News about "Amgen"

Amgen's Dazodalibep Meets Phase 3 OASIZ 301 Goal

Amgen reports positive topline results from the Phase 3 OASIZ 301 study evaluating dazodalibep in adults with Sjögren’s disease and moderate-to-severe systemic disease activity.

Amgen | 23/09/2026 | By News Bureau

US FDA Approves Reduced Monitoring Time for First 2 Doses of Imdelltra

The US Food and Drug Administration (FDA) has approved reduced monitoring time for the first 2 doses of Imdelltra, supporting broader community access for patients with extensive-stage Small Cell Lung Cancer (SCLC).

Amgen | 15/09/2026 | By News Bureau

Imfinzi-Tarlatamab Combination Improves Overall Survival in Phase 3 ES-SCLC Trial

AstraZeneca and Amgen reported statistically significant improvements in overall and progression-free survival with Imfinzi plus tarlatamab versus Imfinzi alone in the Phase 3 DeLLphi-305 trial.

Amgen | 10/09/2026 | By News Bureau

Amgen Announces Positive Phase 3 Results for TEPEZZA

Amgen reports positive Phase 3 topline results for subcutaneous TEPEZZA in thyroid eye disease, with key endpoints met and 77 percent of patients achieving significant proptosis reduction.

Amgen | 07/04/2026 | By News Bureau |  232

Amgen Acquires UK- based Dark Blue Therapeutics in 840M USD Deal

Amgen’s acquisition of Dark Blue Therapeutics, adds a first-in-class protein degrader programme targeting MLLT1/3-driven acute myeloid leukemia to strengthen its early-stage oncology pipeline.<br />

Amgen | 07/01/2026 | By News Bureau |  166

Sanofi and Novartis Reach Separate Agreements with US Government to Lower Drug Prices and Support Innovation

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 |  334

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 |  200

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 |  182

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 |  456

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 |  273