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.
How Kenox Pharmaceuticals is targeting the OINDP CDMO gap with integrated clinical manufacturing
Kenox Pharmaceuticals announces clinical manufacturing readiness for inhaled and nasal drug products. What this means for OINDP development timelines and IVBE strategy.
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.