Regulatory Approvals - Bristol Myers Squibb's Breyanzi received approval as the first CAR T-cell therapy for marginal zone lymphoma [1] - Gamida Cell Ltd.'s Omisirge became the first hematopoietic stem cell transplant therapy for severe aplastic anaemia [2] - Fondazione Telethon's Waskyra is noted as the first cell-based gene therapy for Wiskott-Aldrich syndrome and the first approved cell and gene therapy product from a non-profit applicant [2] Drug Approvals Overview - In 2025, a total of 44 novel drugs have received FDA approval, a decrease from 50 approvals in the previous year [3] - Anticipated regulatory decisions and approvals are expected in January 2026 [3]