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.
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Business News
December 26, 2025 08:42 ET Third quarter economic growth data from some major economies including the U.S. were the main news in this holiday shortened week. GDP growth and industrial production data from the U.S. helped to boost morale, while the consumer confidence survey results were less upbeat. In Europe, the quarterly economic growth data from the U.K. drew attention, while the minutes of the Australian central bank’s latest policy session was in focus in Asia.