FDA hands off its latest whirlwind drug OK as Horizon hustles would-be blockbuster to the market
The FDA isn’t letting its foot off the gas pedal just because it’s January.
The agency came through with an approval for Horizon Therapeutics’ $HZNP new thyroid eye drug Tepezza (teprotumumab), close to two months ahead of the PDUFA date — which was already set early in the year due to a priority review designation. But that sort of thing is becoming routine at the agency, especially if it has a designated “breakthrough therapy” on its hands.
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