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Feb 19, 2026
The European Commission granted conditional marketing authorization for ANKTIVA in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer, expanding the therapy's availability to 33 countries across four regulatory jurisdictions.
Feb 18, 2026
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
Feb 16, 2026
The FDA has accepted for filing the New Drug Application for tirabrutinib under the accelerated approval pathway for relapsed or refractory primary central nervous system lymphoma, setting a PDUFA action date of December 18, 2026.
Feb 14, 2026
The European Commission granted conditional marketing authorization for ANKTIVA plus BCG to treat BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, marking the first approved immunotherapy for this indication in Europe.
Feb 12, 2026
Lyell Immunopharma has initiated dosing in its Phase III PiNACLE – H2H trial, comparing ronde-cel against approved CAR T-cell therapies for relapsed or refractory large B-cell lymphoma in second-line treatment.
