Asha Das, di­rec­tor of the FDA bi­o­log­ics cen­ter's of­fice of clin­i­cal eval­u­a­tion, over­ruled the agen­cy's re­view team in grant­i­ng an ac­cel­er­at­ed ap­proval to Replimune's melanoma...

The phar­ma in­dus­try has suf­fered a de­fin­i­tive loss in its le­gal bat­tle against Medicare ne­go­ti­a­tions.

The Fifth Cir­cuit Court of Ap­peals on Wednes­day re­ject­eda...

Nine new com­pa­nies have an­nounced vol­un­tary drug pric­ing deals with the White House, look­ing to avoid in­dus­try tar­iffs and in­clu­sion in two CMS pi­lot pro­grams...

Pres­i­dent Don­ald Trump an­nounced vol­un­tary drug pric­ing deals with nine new com­pa­nies on Mon­day, for the first time veer­ing out­side of the orig­i­nal crop of...

The dream of mak­ing per­son­al­ized ge­net­ic med­i­cines at a mo­ment’s no­tice just got a ma­jor in­fu­sion of fund­ing from the fed­er­al gov­ern­ment.

Five groups were...

The FDA ap­proved rus­fer­tide, a new drug from Take­da and Pro­tag­o­nist Ther­a­peu­tics to treat a rare blood dis­ease.

Rus­fer­tide, which will be brand­ed as Mim­ry­lo, can...