Drug Approval | April 28, 2025
CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74
Expanded US manufacturing and R&D presence with investment in 10 facilities, including 7 brand new facilities
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis
This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets
Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone
EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults
Will add UNLOXCYT (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) to Sun Pharma's global onco-derm franchise
The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara
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