Un­der new lead­er­ship, FDA of­fi­cials have said they’ll place re­newed em­pha­sis on ad­vi­so­ry meet­ings for con­test­ed prod­uct ap­pli­ca­tions.

Two new an­nounce­ments sug­gest they’re mak­ing good...

The Eu­ro­pean Med­i­cines Agency has pro­posed re­vok­ing the mar­ket­ing au­tho­riza­tion for Am­gen’s con­tro­ver­sial rare dis­ease drug Tavneos cit­ing “in­cor­rect and mis­lead­ing” clin­i­cal da­ta.

The fu­ture...

The Eu­ro­pean Com­mis­sion said it has start­ed an in­ves­ti­ga­tion in­to whether Sanofi flout­ed com­pe­ti­tion rules while mar­ket­ing its en­hanced flu vac­cine for over 60s, known...

Michael Gilman is step­ping down as CEO of Ar­rakis, the com­pa­ny an­nouncedthis week. A press re­lease de­scribed the move as a re­tire­ment af­ter...

Bio­gen has paused or can­celed in­vest­ment in the “ma­jor­i­ty” of re­search pro­grams that came with its $5.6 bil­lion ac­qui­si­tion of Apel­lis Phar­ma­ceu­ti­cals and laid off...

Ake­so lead­er­ship is push­ing back on some of the ques­tions about its next-gen­er­a­tion can­cer drug raised ear­li­er this mo