Manila Times Business
BridgeBio Announces FDA Acceptance and Priority Review of NDA for BBP-418 for LGMD2I/R9
- Accepted for Priority Review with PDUFA target action date of November 27, 2026, and poised to launch upon approval; being granted Priority Review by the FDA reiterates the serious unmet need for treatment options for the LGMD2I/R9 community - If approved, BBP-418 would be the first and only therapy for individuals living with LGMD2I/R9 and would represent the first approved treatment for any form of LGMD - BBP-418 demonstrated strong, consistent efficacy across all prespecified subgroups with
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Source: manilatimes.net
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