Lia DeGroot

Con­sult­ing the FDA on us­ing math­e­mat­i­cal sim­u­la­tions in drug de­vel­op­ment could make the process more ef­fi­cient, sav­ing spon­sors time and mon­ey, a re­port on the

The FDA like­ly won’t re­ceive any more funds through the end of this fis­cal year when com­pared to last year, ac­cord­ing to the first of

The Eu­ro­pean Com­mis­sion is en­cour­ag­ing mem­ber coun­tries to work to­geth­er more ef­fec­tive­ly on as­sess­ing and pay­ing for new ther­a­pies and health tech­nolo­gies with a pro­pos­al

The FDA on Tues­day turned down Van­da Phar­ma­ceu­ti­cals’ re­quest for a hear­ing on is­sues the agency found with the com­pa­ny’s ap­pli­ca­tion for a jet lag

John­son & John­son’s Janssen on Fri­day earned an FDA ap­proval for its can­cer drug Ry­bre­vant (ami­van­tam­ab-vmjw) for the first-line treat­ment of lo­cal­ly ad­vanced or metasta­t­ic

The FDA is aim­ing to make it eas­i­er for clin­i­cal tri­al par­tic­i­pants to un­der­stand in­formed con­sent, of­fer­ing tri­al spon­sors rec­om­men­da­tions for clar­i­fy­ing key in­for­ma­tion, as

HHS’ newest bio­med­ical re­search arm has yet to fi­nal­ize its char­ter for its ad­vi­so­ry com­mit­tee or ex­plain how mem­bers will put their heads to­geth­er to

The Biden ad­min­is­tra­tion is dol­ing out $48 mil­lion to a non­prof­it that wants to use ma­chine learn­ing and ar­ti­fi­cial in­tel­li­gence to iden­ti­fy po­ten­tial rare dis­ease

Ef­forts to in­spect gener­ic drug fa­cil­i­ties around the world could end up wors­en­ing US short­ages of sev­er­al key med­i­cines if they lead to halt­ed man­u­fac­tur­ing,

The De­part­ment of Jus­tice has is­sued a sub­poe­na to Bio­Marin over is­sues with its spon­sored test­ing pro­grams for two of its rare dis­ease drugs, the