Gamida Cell initiates rolling submission of biologics license application for omidubicel

Gamida Cell

9 February 2022 - Gamida Cell today announced that it has initiated the biologics license application rolling submission process with the U.S. Food and Drug Administration for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. 

The company remains on track to complete the submission in the second quarter of 2022.

Read Gamida Cell press release

Michael Wonder

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Michael Wonder

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US , Dossier , Cellular therapy