The FDA has nar­rowed its search for a new leader of its Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search to three or four fi­nal can­di­dates, ac­cord­ing...

Mod­er­na said it's work­ing with US reg­u­la­tors to pro­vide post-mar­ket­ing da­ta on its Covid-19 vac­cines that could re­store their use to a wider group af­ter...

A pow­er­ful spend­ing com­mit­tee in Con­gress wants the FDA to ban the use of clin­i­cal tri­al da­ta from Chi­na in fu­ture ap­pli­ca­tions by drug­mak­ers to...

Am­gen has tak­en steps to up­date its Tavneos la­bel amid an on­go­ing bat­tle with the FDA.

The com­pa­ny filed a sup­ple­menton Wednes­day that would...

The FDA on Fri­day ap­provedPfiz­er and Arv­inas' drug vepdeges­trant for pa­tients with a cer­tain form of breast can­cer. But it’s un­clear how many will...

In its first meet­ing in about nine months, the FDA’s ad­vi­so­ry com­mit­tee of on­col­o­gy ex­perts vot­ed 6-3 Thurs­day that a late-stage tri­al for As­traZeneca’s oral...