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Jun 29, 2026
Grünenthal has successfully completed a Phase I trial for its proprietary nociceptin receptor (NOP) agonist, demonstrating safety and tolerability in 113 healthy volunteers. The company plans to advance the novel pain therapy into a Phase II trial later this year, with results expected in the second half of 2027.
May 05, 2026
Vertex completed the rolling BLA submission for povetacicept in IgA nephropathy after positive Phase 3 RAINIER interim data. The company plans to use a Priority Review Voucher to accelerate FDA review.
May 01, 2025
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
