Selected November goal dates
These rows are taken from the same reviewed dataset as the main calendar. No other November coverage is implied.
Seven selected U.S. application/indication goal dates, reported by sponsors. Not a complete FDA calendar; dates and status can change. Manual review date is separate from source publication date.
2026-11-14
| 2026-11-22 | MOLBREEVI (molgramostim inhalation solution) | Savara | Autoimmune pulmonary alveolar proteinosis | BLA | Under review in sponsor 10-Q; goal date extended | 2026-11-09 | Primary source |
| 2026-11-28 | D-PLEX100 | PolyPid | Prevention of surgical site infections in colorectal surgery | NDA / Priority Review | Under review in sponsor update | 2026-11-11 | Primary source |
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MOLBREEVI: an extended review target
Savara’s November 2026 quarterly filing describes an extension after responses to FDA information requests were treated as a major amendment. The date belongs to its U.S. application for autoimmune pulmonary alveolar proteinosis. European and U.K. reviews are separate records.
Keep the extension and the application together in your notes. An extension alone does not establish the eventual review outcome.
D-PLEX100: goal date and launch are different
PolyPid’s November 11 update gives a November 28 goal date for the NDA in colorectal surgical-site infection prevention. Its potential U.S. commercial launch is a separate, approval-dependent milestone.
When reviewing a company timeline, put FDA action, any approval announcement, and actual product availability in separate fields.
Source notes
- Savara — MOLBREEVI (molgramostim inhalation solution) ↗
Sponsor-reported goal date and indication; source dated 2026-11-09
- PolyPid — D-PLEX100 ↗
Sponsor-reported goal date and indication; source dated 2026-11-11
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