BTD

Innovent’s IBI363 Gains Second China BTD for Resistant Lung Cancer

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China’s National Medical Products Administration has granted a second Breakthrough Therapy Designation to Innovent Biologics’ IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, for treating immunotherapy-resistant squamous non-small cell lung cancer (sqNSCLC). The designation applies to unresectable, locally advanced, or metastatic sqNSCLC that has progressed following anti-PD-(L)1 immunotherapy and platinum-based chemotherapy. This marks IBI363’s fourth … Read more

Randox Gains FDA De Novo Clearance for Hemophilia CDx

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Randox Laboratories has secured FDA de novo clearance for its ConcizuTrace ELISA companion diagnostic, designed to quantify plasma concentrations of Novo Nordisk’s recently approved hemophilia treatment Alhemo (concizumab-mtci). The regulatory milestone comes just weeks after Alhemo received FDA approval in December 2024 as a once-daily prophylactic injection for adults and pediatric patients 12 years and … Read more

Regulatory Roundup: Weekly Insights on Pharma and MedTech—Key Updates from Leading Agencies (December 30th to January 3rd) 

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Welcome to this week’s Regulatory Insights from Synopulse, featuring the latest updates from the FDA, EMA, and other global regulatory authorities. From groundbreaking drug approvals to critical recalls and new designations, we cover the most significant events driving the pharmaceutical sector. This comprehensive report offers a concise view of the regulatory milestones shaping the pharma, … Read more