Amid Ger­many's on­go­ing re­view of its health­care spend­ing, the US gov­ern­ment has start­ed a trade in­ves­ti­ga­tion in­to the Eu­ro­pean coun­try's drug pric­ing sys­tem.

The in­ves­ti­ga­tion...

The Trump ad­min­is­tra­tion is re­spond­ing to a drum­beat of calls from the biotech and phar­ma in­dus­tries to mod­ern­ize and ex­pe­dite clin­i­cal tri­als with a sweep­ing...

Did you re­ceive a com­plete re­sponse let­ter in the past year? Now may be the time for a re­sub­mis­sion.

In the wake of FDA Com­mis­sion­er...

Re­genxbio said that it plans to re­sub­mit its Hunter syn­drome gene ther­a­py fol­low­ing an­oth­er ap­par­ent walk back by the FDA af­ter lead­er­ship de­par­tures.

Ac­cord­ing to...

Med­ica­tion us­age, par­tic­u­lar­ly for the most ex­pen­sive drugs, in­creased sig­nif­i­cant­ly short­ly af­ter the Medicare an­nu­al out-of-pock­et cost cap took ef­fect in Jan­u­ary 2025, a study...

Every mem­ber of a vac­cine ad­vi­so­ry pan­el for the FDA vot­ed in fa­vor of Mod­er­na’s flu vac­cine, af­ter the prod­uct faced road­blocks from pre­vi­ous agency...

The FDA has is­sued a new batch of warn­ing let­ters to 25 tele­health com­pa­nies, ac­cus­ing them of mak­ing false and mis­lead­ing claims in their mar­ket­ing...