Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Biogen, BMS, Eisai, Innovent, Novartis, Otsuka, Regeneron, Sanofi, Sarepta, Teva.
In October 2025, BioWorld tracked 252 clinical trial updates across phases I-III, roughly in line with September’s 230 but markedly higher than the 95 logged in August. Of those, 27 phase III studies reported positive results, while four disclosed failures. Clinical trial updates logged by BioWorld in October comprised 91 phase I reports, 75 from phase II, and 87 from phase III studies.
Myrio Therapeutics Pty Ltd. has been able to accomplish something no other company has yet been able to crack: to develop binders where both the affinity and the specificity can be increased.
Vigencell Inc. plans to seek conditional approval in South Korea for VT-EBV-N, an antigen-specific killer T-cell therapy for natural killer T-cell lymphoma, after gaining positive top-line data from a phase II study Nov. 25.