FDA ad­comm votes in fa­vor of new an­ti­fun­gal; De­nali gets $25M from Sanofi MS tri­al mile­stone

The FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee vot­ed 14-1 in fa­vor of a lim­it­ed-use in­di­ca­tion for Cidara Ther­a­peu­tics’ reza­fun­gin, a treat­ment for can­didemia and in­va­sive can­didi­a­sis.

Ac­cord­ing to Cidara on Wednes­day, the vote was based on da­ta from two tri­als run by Cidara, with a once-week­ly dose of reza­fun­gin demon­strat­ing sta­tis­ti­cal non-in­fe­ri­or­i­ty ver­sus caspo­fun­gin, the cur­rent stan­dard.

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