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Jul 24, 2026
The FDA launched two pilots to boost domestic manufacturing: PreCheck selected seven companies for earlier engagement, and a CVM pilot prioritizes animal drug applications with US-made ingredients.
Jun 12, 2026
Updated KOMET-007 trial data show ziftomenib plus chemotherapy achieves 94% twelve-month overall survival in newly diagnosed NPM1-mutant AML. The oral menin inhibitor, approved by the FDA in November 2025 for relapsed/refractory disease, is being evaluated in a Japanese Phase II trial and a global Phase 3 study.
Apr 27, 2026
Kyowa Kirin and Kura Oncology started a Japanese Phase II registrational study of ziftomenib in adults with relapsed or refractory NPM1-mutated AML. Kyowa Kirin plans to seek regulatory approval in Japan after the trial.
Mar 24, 2026
The FDA has approved Bristol Myers Squibb's CAR-T therapy Breyanzi for relapsed/refractory marginal zone lymphoma, while a novel multiple myeloma drug candidate DTP3 advances to Phase 2 trials after showing promising early results. Both developments represent significant progress in blood cancer treatment, with the marginal zone lymphoma approval based on a 95.5% response rate and the myeloma drug demonstrating selective cancer cell killing without toxicity.
