Page 92 - Priority Review News Today

Topline results were announced from a large global phase 3 confirmatory study of lecanemab for the treatment of early Alzheimer disease.

The FDA has accepted for Priority Review the NDA for leniolisib to treat activated phosphoinositide 3-kinase delta syndrome.

Dupixent (dupilumab) approved by FDA as the first and only treatment indicated for prurigo nodularis Dupixent significantly reduced itch and skin lesions compared to placebo in direct-to-Phase 3 program

/PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved...

Seagen and LAVA Therapeutics inked a licensing deal for LAVA's Gammabody platform for solid tumors, which can potentially exceed $700 million.

Bracco Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Gadopiclenol Injection, a new, highly stable macrocyclic gadolinium-based contrast agent (GBCA). The introduction of VUEWAY injection is the result of a strategic, global collaboration between Bracco and Guerbet in both research, development, and manufacturing of the product signed in December 2021.

/PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB),...

The FINANCIAL -- Merck, known as MSD outside the United States and Canada, on August 18 announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy. The FINANCIAL -- Merck, known as MSD outside the United States and Canada, on August 18 announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for K...

The FDA has accepted for Priority Review the NDA for rezafungin, a novel echinocandin, for the treatment of candidemia and invasive candidiasis.

The FDA has accepted for Priority Review the sNDA for tucatinib plus trastuzumab for adults with HER2-positive colorectal cancer.