News about "monoclonal antibody "

Mirum's Brelovitug Meets Phase 3 Endpoint in Chronic Hepatitis Delta

Mirum Pharmaceuticals reports positive Phase 3 AZURE-1 results for brelovitug, with the investigational antibody meeting its primary endpoint in chronic HDV.

Monoclonal Antibody | 29/09/2026 | By News Bureau

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 |  241

Innovent's Tri-Specific Antibody IBI3003 Secures FDA Fast Track Status for Relapsed/Refractory Multiple Myeloma

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 |  341

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 |  1053

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 |  319

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 |  236

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 |  662

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 |  313