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May 15, 2026
The FDA's January draft guidance proposes MRD-negative complete response as an accelerated approval end point for multiple myeloma drugs. It defines MRD negativity, sets trial design requirements, and accepts comments through March 23, 2026. Expert Nicholas Richardson discusses calibration challenges and the single-trial model.
May 21, 2026
The FDA approved Novocure’s Optune Pax, a wearable tumor-treating fields device, for pancreatic cancer in combination with chemotherapy. Phase III PANOVA-3 data showed delayed pain progression and improved one-year overall survival in inoperable locally advanced disease.
Feb 13, 2026
The FDA has approved Optune Pax, a wearable device delivering tumor treating fields for locally advanced pancreatic cancer. The approval marks the first new treatment modality for this indication in nearly 30 years.
