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News about "monoclonal antibody "
Lundbeck's Asedebart Receives EU Orphan Designation for Cushing's Syndrome
Lundbeck’s asedebart receives orphan designation in the European Union for Cushing’s syndrome, supporting its development as a potential targeted therapy for ACTH-driven endocrine disorders.
Monoclonal Antibody | 25/08/2026 | By News Bureau
US FDA Approves Dr Reddy's Rituximab Biosimilar for the US Market
Dr Reddy's Laboratories has secured US FDA approval for its rituximab biosimilar, expanding its global biosimilars portfolio and strengthening its presence in the US biologics market.
Monoclonal Antibody | 03/08/2026 | By News Bureau
Innovent Biologics Licenses Anti-CD40L Therapy IBI355 to Spero Therapeutics in USD 1.1 Billion Deal
Innovent Biologics has licensed global rights outside Greater China for its anti-CD40L antibody IBI355 to Spero Therapeutics in a deal valued at up to USD 1.1 billion, advancing the development of a potential new treatment for autoimmune diseases including IgG4-related disease and Sjögren's disease.
Monoclonal Antibody | 15/07/2026 | By News Bureau | 188
Innovent Biologics’ tri-specific antibody IBI3003 has received FDA Fast Track Designation for heavily pretreated relapsed or refractory multiple myeloma, supported by promising early clinical efficacy and safety data.
Monoclonal Antibody | 27/01/2026 | By News Bureau | 293
Boehringer Ingelheim Begins Phase IIa Trial of BI 765423 in IPF
Boehringer Ingelheim has initiated a Phase IIa clinical trial of BI 765423, a novel IL-11–targeting monoclonal antibody, in patients with Idiopathic Pulmonary Fibrosis (IPF), advancing its efforts to develop new treatment options for progressive fibrotic lung diseases.
Monoclonal Antibody | 15/01/2026 | By News Bureau | 960
Amneal Gains US FDA Approval for Prolia and XGEVA Denosumab Biosimilars
The US FDA approvals for Prolia and XGEVA denosumab biosimilars strengthen Amneal’s growing biosimilars portfolio, with the company planning to commercialise six biosimilars across eight presentations by 2027.
Monoclonal Antibody | 23/12/2025 | By News Bureau | 258
ADEL Signs USD 1.04 Billion Global Licensing Deal with Sanofi for Alzheimer's Drug
ADEL has signed a global licensing deal with Sanofi for its investigational Alzheimer’s therapy ADEL-Y01, valued at up to USD 1.04 billion, including a USD 80 million upfront payment, milestone payments and royalties.
Monoclonal Antibody | 16/12/2025 | By News Bureau | 189
Merck Expands Tulisokibart Phase-2(b) Trials Across Three Inflammatory Diseases
Tulisokibart is an investigational anti-TL1A monoclonal antibody currently in Phase-3 trials for Ulcerative Colitis and Crohn’s disease, to be studied in hidradenitis suppurativa, radiographic axial spondyloarthritis and Rheumatoid Arthritis.
Monoclonal Antibody | 07/10/2025 | By Dineshwori | 610
BioDlink Launches Bevacizumab Biosimilar in Colombia and Pakistan
BioDlink’s bevacizumab injection secures marketing authorization in Colombia and Pakistan following its recent approval in Nigeria.<br />
Monoclonal Antibody | 14/08/2025 | By Dineshwori | 288
Spyre Therapeutics Initiates Dosing of First Participant in Phase 1 Trial of SPY003
The SPY003 Phase 1 Trial (NCT06873724) is a double-blind, placebo-controlled single-ascending dose study in healthy volunteers.
Monoclonal Antibody | 31/03/2025 | By Aishwarya | 386
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