No FDA advisory committee for MOLBREEVI: what Savara’s Day 74 Letter means for the August PDUFA review
Savara’s molgramostim BLA faces no FDA adcom. Analysis of what the August 2026 PDUFA date means for autoimmune PAP treatment access. Read more.
Savara selects PANTHERx as exclusive pharmacy for MOLBREEVI amid PAP BLA review
Savara names PANTHERx as exclusive pharmacy for MOLBREEVI in autoimmune PAP. Find out what this launch model means for access, adoption, and strategy.
How Hansa Biopharma is targeting a transplant blind spot with Imlifidase
Hansa Biopharma AB has submitted a Biologics License Application to the U.S. Food and Drug Administration for imlifidase as a desensitization treatment in highly sensitized adult patients awaiting deceased donor kidney transplants. The submission is supported by the pivotal Phase 3 ConfIdeS trial, and the company is seeking a priority review that could lead to […]