Novartis' Exjade Goes To Blood Products Committee Sept. 29
This article was originally published in The Pink Sheet Daily
Advisory committee likely to discuss iron chelator’s failure to show non-inferiority to existing treatment in 1,000-patient clinical program.
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Subset analysis conducted by Novartis may show Exjade benefit in certain patients at higher doses, according to FDA background documents for the Sept. 29 Blood Products Advisory Committee meeting.
The Irvine, Calif., firm also plans sNDAs for a colorectal cancer claim and an oral formulation of the leucovorin relative.