Gossamer Bio, Inc.
seralutinib
pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)
Date
TBD
FDA decision · Date TBD estimated
What's at stake
An FDA complete response letter on seralutinib for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) is in focus around Date TBD.
Primary source
· SEC 8-K
verified 14h ago
“The Company has requested and received confirmation of an in-person Pre-NDA Type B meeting with the U.S. Food and Drug Administration (FDA), scheduled for mid-June.”