Drug Approval | November 23, 2025
Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER
Tofacitinib extended-release tablets are a Janus kinase inhibitor indicated for Rheumatoid Arthritis
Tofacitinib extended-release tablets are a Janus kinase inhibitor indicated for Rheumatoid Arthritis
HER2-mutant NSCLC typically has a poor prognosis and limited treatment options
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets
Global Phase 3 MANEUVER study highlights ongoing benefits and consistent safety profile
Zaltenibart offers best-in-class potential across multiple rare blood and kidney disorders, enhancing Novo Nordisk’s rare disease portfolio
Updated indication expands treatment options for patients with ulcerative colitis and Crohn’s disease when tumor necrosis factor (TNF) blockers are clinically inadvisable
New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations
The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A
The submission is supported by positive results from the Phase 3 AMPLIFY trial
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