Lia DeGroot

The FDA on Fri­day with­drew an ac­cel­er­at­ed ap­proval for Helsinn’s bile duct can­cer drug, two years af­ter the com­pa­ny couldn’t com­plete its con­fir­ma­to­ry tri­al and

The FDA has work to do to earn the con­fi­dence of cer­tain groups of peo­ple who do not trust the agency, a study pub­lished Fri­day

WASH­ING­TON — Law­mak­ers ad­vanced the reau­tho­riza­tion of an FDA pro­gram de­signed to stim­u­late the de­vel­op­ment of treat­ments for pe­di­atric rare dis­eases, de­spite some op­po­si­tion from

The FDA is pro­vid­ing spon­sors of cell ther­a­pies with a new draft guid­ance doc­u­ment on the kinds of safe­ty test­ing they should per­form. The 14-page

Mem­ber coun­tries of the World Health Or­ga­ni­za­tion said they failed to agree on a draft of a long-await­ed pan­dem­ic agree­ment by a dead­line last week, but

Drug­mak­ers would have un­til 2032 to cut ties with WuXi AppTec and oth­er Chi­nese life sci­ences com­pa­nies, ac­cord­ing to an up­dat­ed draft of the close­ly

In the lead-up to the like­ly ap­proval of Geron’s drug to treat cer­tain types of ane­mia, drug pric­ing watch­dog the In­sti­tute for Clin­i­cal and Eco­nom­ic

The House Ways and Means com­mit­tee on Wednes­day marked up leg­is­la­tion that would re­quire phar­ma­cy ben­e­fit man­agers to de-link their com­pen­sa­tion from the price of

The White House Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy on Tues­day re­leased its long-await­ed pol­i­cy plans for over­see­ing re­search that pos­es risks if mis­ap­plied. The

House Over­sight Com­mit­tee Chair James Com­er (R-KY) is press­ing the FDA to share more in­for­ma­tion on its pres­ence in Chi­na amid grow­ing con­cerns on Capi­tol