News about "monoclonal antibody "

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

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 177

Boehringer Ingelheim Begins Phase IIa Trial of BI 765423 in IPF

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 514

Amneal Gains US FDA Approval for Prolia and XGEVA Denosumab Biosimilars

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 178

ADEL Signs USD 1.04 Billion Global Licensing Deal with Sanofi for Alzheimer's Drug

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 107

Merck Expands Tulisokibart Phase-2(b) Trials Across Three Inflammatory Diseases

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 427

BioDlink Launches Bevacizumab Biosimilar in Colombia and Pakistan

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 234

Spyre Therapeutics Initiates Dosing of First Participant in Phase 1 Trial of SPY003

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 320

Syngene Acquires its First Manufacturing Facility in US

Syngene Acquires its First Manufacturing Facility in US

The new site will increase Syngene's total single-use bioreactor capacity to 50,000L for large molecule discovery, development, and manufacturing services.

Monoclonal Antibody | 11/03/2025 | By Aishwarya 514

GBI and Allterum to Manufacture Therapeutic Antibody for Clinical Trials

GBI and Allterum to Manufacture Therapeutic Antibody for Clinical Trials

With this collaboration, GBI will leverage their extensive expertise in manufacturing complex biologics to ensure the high-quality production of 4A10 for Phase 1/2a clinical trials.

Monoclonal Antibody | 08/10/2024 | By Aishwarya 355

Sanofi Begins Shipping BEYFORTUS in US

Sanofi Begins Shipping BEYFORTUS in US

Sanofi has started shipping BEYFORTUS (nirsevimab-alip) 50mg and 100mg Injection doses in the US to private healthcare providers and to the Centers for Disease Control and Prevention for its vaccines for children program.

Monoclonal Antibody | 18/09/2024 | By Aishwarya 452


 

 

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