FDA may re­quire bis­pe­cif­ic an­ti­bod­ies to be com­pared with mono­spe­cif­ic prod­ucts

With about 100 bis­pe­cif­ic an­ti­bod­ies ei­ther in clin­i­cal tri­als or soon en­ter­ing, the FDA on Mon­day up­dat­ed and fi­nal­ized its guid­ance on de­vel­op­ing bis­pe­cif­ic an­ti­bod­ies …

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