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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER