A go-go FDA is poised to break the all-time record on new drug ap­provals. Is this the new stan­dard for bio­phar­ma suc­cess?

Last year at this time, the FDA was be­gin­ning to reach in­to Q1 of 2018 to hur­ry up a slate of new drug ap­provals that pushed the agency to a new record high, both a cur­rent-gen­er­a­tion agency best as well as an over­all spike that broke in­to vir­gin ter­ri­to­ry for the first time in 20 years — pro­vid­ed you added a group of ma­jor new bi­o­log­ics to the new ther­a­peu­tics list.

This year, it looks like the FDA will have the lux­u­ry of break­ing through the fin­ish line at the end of De­cem­ber af­ter putting the old record — set in 1996 — to shame just by stick­ing with the PDU­FA dates on hand. And they’ve proven be­yond doubt that they’re not like­ly to do that.

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