FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients

FDA approved Decnupaz (pivekimab sunirine-pvzy) for the treatment of adult patients with BPDCN, an ultra-rare and aggressive hematologic malignancy with limited treatment options. The approval is supported by data from the phase I/II CADENZA trial, a global study evaluating the safety and efficacy of Decnupaz for BPDCN.

FDA has approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis. Hepcludex is the first FDA-approved treatment for chronic HDV infection, a serious and life-threatening condition that can cause rapid development of liver fibrosis, liver cancer, liver failure, and even death.