The FDA and Capri­cor Ther­a­peu­tics of­fered sharply op­posed in­ter­pre­ta­tions of clin­i­cal da­ta back­ing the com­pa­ny's po­ten­tial new cell ther­a­py for the rare and fa­tal Duchenne...

The FDA is again ques­tion­ing the ef­fi­ca­cy of Capri­cor's cell ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy, this time ahead of an ad­vi­so­ry com­mit­tee meet­ing on Wednes­day...

Neil Vasan, act­ing chair of the FDA's On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee, told End­points Newsthat he's stepped down from the com­mit­tee. He's par­tic­i­pat­ed in 22...

Mer­ck CEO Rob Davis said he has warned Con­gress and the Trump ad­min­is­tra­tion that if they cut off or ham­per US-Chi­na deal­mak­ing, the US could lose...

FDA staff threw cold wa­ter on Replimune’s ad­vanced melanoma drug ahead of a crit­i­cal meet­ing with agency ad­vi­sors, writ­ing that the piv­otal study de­sign failed...

Af­ter two days of meet­ings, an FDA ad­vi­so­ry com­mit­tee last week vot­ed to lift re­stric­tions on six pop­u­lar health and well­ness pep­tides, set­ting aside FDA...

At a time when the fed­er­al gov­ern­ment is eval­u­at­ing re­stric­tions on med­ica­tion abor­tion, a fed­er­al judge de­ter­mined that the last ad­min­is­tra­tion im­posed too many.

A...