14 July 2025
14 July 2025
The FDA's request stems from observations made during recent inspections of Ultragenyx's manufacturing facilities.
GSK looks to compete with Pfizer and Moderna in the 18-49 age group of the RSV vaccine market in the US.
Tevimbra is a specially engineered humanised immunoglobulin G4 monoclonal antibody.
MSD’s NDA is supported by week 48 data from two Phase III trials, MK-8591A-051 and MK-8591A-052.
By disclosing the CRLs, the FDA provides an insight into common pitfalls that sponsors must rectify to gain approval.
IGI Therapeutics will be entitled to $1.225bn on reaching development milestones and targets.
The US dominates overall market sales, yet GlobalData research indicates that China is shaping up to be a formidable presence in the cell therapy space.
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