Lia DeGroot

The Mass­a­chu­setts-based biotech Lu­mi­cell won FDA ap­proval on Thurs­day for its drug-de­vice com­bi­na­tion prod­uct used to help de­tect resid­ual can­cer in breast can­cer pa­tients, the

Man­u­fac­tur­er Nat­co Phar­ma was hit with a warn­ing let­ter ear­li­er this month over vi­o­la­tions at its fa­cil­i­ty in the In­di­an state of Telan­gana, fol­low­ing an

The Gov­ern­ment Ac­count­abil­i­ty Of­fice put sev­er­al states’ reg­u­la­tions around phar­ma­cy ben­e­fit man­agers un­der a mi­cro­scope, find­ing that states fa­vor broad au­thor­i­ty over PBMs, in a

The FDA on Mon­day launched a new hub fo­cused on in­no­vat­ing in clin­i­cal tri­als as part of wider ef­forts to make drug de­vel­op­ment more ef­fi­cient.

The Eu­ro­pean Med­i­cines Agency found no link be­tween semaglu­tide use and sui­ci­dal thoughts or ac­tions, con­clud­ing a month­s­long probe that fol­lowed an in­quiry by the

WASH­ING­TON — FDA Com­mis­sion­er Robert Califf ap­peared be­fore the House Over­sight Com­mit­tee on Thurs­day to plead his case again for more au­thor­i­ty to mon­i­tor the

En­do Phar­ma­ceu­ti­cals is su­ing the FDA over its ap­proval of a gener­ic ver­sion of En­do’s Adren­a­lin in­jec­tions to treat al­ler­gic re­ac­tions, re­quest­ing an emer­gency stay

Sev­er­al in­dus­try stake­hold­ers are ask­ing the FDA to stream­line its process­es for work­ing with spon­sors on com­plex and in­no­v­a­tive de­signs for clin­i­cal tri­als. The com­ments

Vir­ginia Gov. Glenn Youngkin ve­toed leg­is­la­tion late Mon­day that would have es­tab­lished an ad­vi­so­ry board to bet­ter man­age the state’s pre­scrip­tion drug costs. Oth­er states

Al­most half of can­cer drugs that re­ceived ac­cel­er­at­ed ap­proval didn’t end up im­prov­ing qual­i­ty of life or sur­vival af­ter five years of fol­low-up, Har­vard Uni­ver­si­ty