Tag: FDA
-
GRAIL’s Galleri Wins FDA Panel Backing for Multi-Cancer Blood Test
FDA advisers backed GRAIL’s Galleri multi-cancer blood test, but a split effectiveness vote leaves key questions ahead of the final PMA decision.
-
Takeda Wins FDA Approval for First-in-Class Mimrylo in Polycythemia Vera
The FDA approved Mimrylo (rusfertide), the first hepcidin mimetic for polycythemia vera, introducing iron restriction as a new strategy to control excessive red blood cell production.
-
LEO Pharma Bets Up to $435 Million on Oral Therapy for Rare Sunlight-Induced Pain
LEO Pharma is acquiring global rights to dersimelagon from Tanabe Pharma in a deal worth up to $435 million. The oral MC1R agonist has completed Phase 3 development in erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) and has already been submitted to the FDA.