Biotech Stocks Facing FDA Decision In January 2026

(RTTNews) - The regulatory landscape saw several historic firsts in terms of FDA approval in December. Among them are the approval of Bristol Myers Squibb's Breyanzi - the first CAR T-cell therapy for marginal zone lymphoma, and the introduction of TEMPO, a first-of-its-kind digital health pilot aimed at expanding access to chronic disease technologies, developed by the FDA's Center for Devices and Radiological Health.

The FDA also cleared Gamida Cell Ltd.'s Omisirge, the first hematopoietic stem cell transplant therapy for patients with severe aplastic anaemia, and Fondazione Telethon's Waskyra, the first cell-based gene therapy for Wiskott-Aldrich syndrome and also the first approved cell and gene therapy product from a non-profit applicant.

So far in 2025, 44 novel drugs have received FDA approval, compared to 50 in the prior year. Against this backdrop, let's take a look at the key regulatory decisions and anticipated approvals slated for January 2026.