Synopulse Weekly: Top Deals, FDA Moves & Pricing Insights
Top biopharma deals, FDA approvals, and market access news from the past week.
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Month: June 2025
Innovent’s IBI363 Gains Second China BTD for Resistant Lung Cancer
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...
Read MoreNICE Endorses Linzagolix for NHS Endometriosis Care
The National Institute for Health and Care Excellence (NICE) has approved linzagolix combined with hormonal add-back therapy for endometriosis treatment within the NHS, expanding therapeutic options for an estimated 1.5 million...
Read MoreCAT-os Tool Addresses Global Orthopedic Surgery Gap
A validated capacity assessment tool designed to strengthen orthopedic surgery capabilities in low- and middle-income countries (LMICs) has demonstrated excellent reliability and practical utility in pilot testing, addressing a...
Read MoreRandox Gains FDA De Novo Clearance for Hemophilia CDx
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...
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