The FDA today granted accelerated approval to the second biomarker-based indication for Merck’s pembrolizumab (Keytruda), an anti-PD-1 therapy, regardless of tumor type. A companion diagnostic to pembrolizumab, FoundationOne CDx was also today approved by the FDA as only approved companion diagnostic to measure tumor mutational burden.
The FDA approved Bristol Myers Squibb’s ozanimod (Zeposia) 0.92 mg as an oral treatment for relapsing forms of multiple sclerosis (RMS). Ozanimod can be used to treat clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
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