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FDA BLA

PharmaDeviceNews FDA BLA
Savara's molgramostim clears FDA advisory committee hurdle, but the harder regulatory work is just beginning
Pharma & Biotech

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.

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Pharma & Biotech

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.

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A representative image of a kidney prepared for transplant in a sterile surgical setting. As new desensitization therapies like Imlifidase advance toward FDA review, the promise of expanding access to organ transplantation for highly sensitized patients is gaining renewed attention.
Pharma & Biotech

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

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