Page 13 - Priority Review News Today

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.

The sBLA is supported by data from the phase 3 NRG-GY018 trial, which included patients with stage III-IV or recurrent endometrial carcinoma whose cancer was either pMMR or dMMR.

Winter is far from over in the north, and temperatures in February typically remain below the freezing mark. And with freezing temperatures comes the risk of frostbite.

Latest approvals by the U.S. Food and Drug Administration include Iovance Biotherapeutics Inc.'s Amtagvi - the first cellular therapy indicated for the treatment of unresectable or metastatic melanoma, as well as Genentech's Xolair- the first medication to help reduce allergic reactions to multiple foods after accidental exposure.

AstraZeneca's Tagrisso approved in the US for EGFRm non-small cell lung cancer with chemotherapy. FLAURA2 trial results show significant benefit.

Patients in the US with epidermal growth factor receptor mutated (EGFRm) advanced lung cancer can now receive an important new treatment option delaying disease progression by nearly nine additional months.