Drug Approval | June 12, 2025
FDA approves Merck’s enflonsia for prevention of RSV in infants
Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months
Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A
IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma
Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis
The new site will increase Syngene's total single-use bioreactor capacity to 50,000L
This program aims to develop a fully human monoclonal antibody against a novel immune checkpoint protein that enables T cell activation
Overall investment in the US facility is estimated around US$50 million
The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara
YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis
Findings to form the basis for a Phase 3 program, anticipated to start in H2 2025
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