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Mar 02, 2026
The FDA has accepted New Drug Applications for rusfertide in polycythemia vera with Priority Review and tirabrutinib for relapsed/refractory primary CNS lymphoma under Accelerated Approval, with PDUFA dates set for Q3 2026 and December 2026 respectively.
Feb 27, 2026
Neoadjuvant pembrolizumab achieved 71% pathologic complete response in desmoplastic melanoma patients, while lower-dose ipilimumab combination therapy showed improved survival and fewer side effects in advanced melanoma treatment.
Feb 24, 2026
The FDA accepted a new drug application for tirabrutinib to treat relapsed or refractory primary central nervous system lymphoma, with a decision expected December 18, 2026. The application is supported by phase 2 trial data showing a 67% overall response rate.
