Lia DeGroot

The Fed­er­al Trade Com­mis­sion and De­part­ment of Health and Hu­man Ser­vices are band­ing to­geth­er to glean in­for­ma­tion on how two types of phar­ma mid­dle­men —

The FDA on Tues­day ap­proved Ipsen’s can­cer drug Onivyde as the first-line treat­ment for a type of pan­cre­at­ic can­cer, to be used along­side oth­er can­cer

A vouch­er pro­gram de­signed to stim­u­late drug de­vel­op­ment for rare pe­di­atric dis­eases will sun­set lat­er this year if law­mak­ers don’t reau­tho­rize it — and rare

The FDA laid out con­sid­er­a­tions for how spon­sors should lever­age com­mit­tees to help an­a­lyze clin­i­cal tri­al da­ta in draft guid­ance pub­lished Mon­day. The draft ar­rives

The FDA on Fri­day is­sued a fi­nal rule ex­plain­ing how spon­sors can use mas­ter files — sub­mis­sions to the agency with de­tails on their man­u­fac­tur­ing

The House of Rep­re­sen­ta­tives on Wednes­day cleared a bill that would ban fed­er­al health pro­grams from us­ing qual­i­ty-ad­just­ed life years — a mea­sure­ment of how

The House Com­mit­tee on Over­sight and Ac­count­abil­i­ty on Tues­day ad­vanced leg­is­la­tion that would ban some com­mon prac­tices of phar­ma­cy ben­e­fit man­agers — the mid­dle­men who

A sub­com­mit­tee of the House En­er­gy & Com­merce Com­mit­tee dug in­to the FDA’s for­eign in­spec­tion op­er­a­tions at a hear­ing to­day as the agency still works

Man­u­fac­tur­ers of GLP-1s are shield­ing their prod­ucts with in­tri­cate webs of in­tel­lec­tu­al prop­er­ty pro­tec­tion known as patent thick­ets and are do­ing so more ag­gres­sive­ly than

Van­da Phar­ma­ceu­ti­cals said on Mon­day that the FDA no­ti­fied the com­pa­ny of sev­er­al de­fi­cien­cies in the sup­ple­men­tal new drug ap­pli­ca­tion for its in­som­nia med­ica­tion Het­lioz,