Expanding Cells, Expanding Access: Gamida Cell’s Omisirge Debuts New Donor Source For Stem Cell Transplant
Pink Sheet’s Drug Review Profile follows the FDA’s navigation of the first expanded umbilical cord blood graft with the first indication grounded in neutrophil recovery and infection incidence data.
You may also be interested in...
Gamida Cell Bounces Back With Omisirge US Approval
The Israeli firm Gamida Cell’s lead candidate has obtained a US approval as a new donor source for allogeneic stem cell transplant with the chips in place for independent commercialization despite its recent financial troubles.
US FDA Calls For Clinical Trial Diversity Plan ‘As Soon As Practicable’ In Product Development
Draft guidance outlines Race and Diversity Plan that would reify some of FDA’s efforts to increase racial and ethnic diversity in clinical trials with a mechanism that is applicable from IND through approval.
Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else
Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.