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Regulatory calendar

Primary sources — PDUFA Calendar

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Source register

10 records
Savara — MOLBREEVI (molgramostim inhalation solution)Sponsor-reported goal date and indication; source dated 2026-11-09
PolyPid — D-PLEX100Sponsor-reported goal date and indication; source dated 2026-11-11
Corcept Therapeutics — RelacorilantSponsor-reported goal date and indication; source dated 2026-11-03
Hansa Biopharma — ImlifidaseSponsor-reported goal date and indication; source dated 2026-11-11
Praxis Precision Medicines — Ulixacaltamide HClSponsor-reported goal date and indication; source dated 2026-11-09
Agios Pharmaceuticals — MitapivatSponsor-reported goal date and indication; source dated 2026-11-05
FDA — PDUFA VIIProgram context and official review commitments
Synoptic SEC EDGAR streamConfirmed SEC stream destination
Synoptic REST referenceDocumented metadata and post interfaces
Synoptic MCP guideResearch access and permissions

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