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The FDA has accepted for Priority Review the sBLA for the SC formulation of efgartigimod alfa plus hyaluronidase-qvfc for the treatment of CIDP.
If vorasidenib receives full approval, it would be a first-in-class target therapy to treat individuals with IDH-mutant gliomas.
The NDA is supported by results from the phase 3 INDIGO trial, which included patients 12 years of age and older with residual or recurrent grade 2 glioma with confirmed IDH1 or IDH2 gene mutation who had undergone surgery as their only treatment.
TARRYTOWN, N.Y., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. REGN today announced that the U.S. Food and Drug Administration (FDA) has…
A biologics license application for linvoseltamab in relapsed/refractory multiple myeloma has been accepted for priority review by the FDA.