FDA+ channel feed

FDA asks Bio­gen and Ei­sai to pro­vide more da­ta on sub­cu­ta­neous Leqem­bi

Last year
Pharma

FDA gives the green light to As­traZeneca's rare blood dis­or­der drug Voydeya, fol­low­ing ap­proval in Japan

Last year

Gilead scores ex­pand­ed la­bel for he­pati­tis B drug Vem­lidy in chil­dren 6 years and old­er

Last year
Pharma

Bernie Sanders im­plores No­vo to cut list prices of Ozem­pic, We­govy

Last year
Pharma

Up­dat­ed: FDA ap­proves Ake­bi­a's ane­mia drug af­ter say­ing no in 2022

Last year
Pharma

FDA’s CDER es­tab­lish­es new cen­ter of ex­cel­lence fo­cused on quan­ti­ta­tive med­i­cine

Last year
Pharma

FDA ap­proves Mer­ck­'s rare PAH drug at cen­ter of $11.5B Ac­celeron deal

Last year
Pharma

SCO­TUS rais­es ques­tions over le­gal stand­ing in abor­tion pill case

Last year
Pharma
Law

Astel­las wins ap­proval in Japan for Claudin18.2 ther­a­py af­ter US re­jec­tion

Last year
Pharma

ARPA-H calls on AI de­vel­op­ers to help tack­le cy­ber­at­tacks

Last year
AI
Health Tech

Up­dat­ed: FDA re­jects Re­gen­eron's bis­pe­cif­ic for lym­phoma over con­fir­ma­to­ry tri­al sta­tus

Last year

J&J's Acte­lion buy­out pays off again with ap­proval of Op­syn­vi in pul­monary ar­te­r­i­al hy­per­ten­sion

Last year
Pharma

Es­pe­ri­on eyes new com­mer­cial push for cho­les­terol-low­er­ing drugs af­ter big FDA la­bel ex­pan­sion

Last year
Pharma

FDA to delete 'Y­ou are not a horse' post and oth­ers in iver­mectin case set­tle­ment

Last year
Pharma
Marketing

Sen­a­tors push HHS on ‘in­ad­e­quate’ re­sponse to Change Health­care cy­ber­at­tack

Last year
Health Tech

FDA ap­proves Ital­far­ma­co’s drug Du­vyzat for Duchenne mus­cu­lar dy­s­tro­phy

Last year
Pharma

Glob­al AIDS pro­gram re­vived in gov­ern­ment spend­ing pack­age as oth­er health rid­ers fall off

Last year
Pharma

Ken­tucky is the fourth state to al­low in­sur­ers to re­quire biosim­i­lar pre­scrip­tions be­fore brand­ed ver­sions

Last year
Pharma

FDA ap­proves Idor­sia’s high blood pres­sure drug for pa­tients who need oth­er op­tions

Last year
Pharma

When can ob­ser­va­tion­al stud­ies sup­port a drug's ef­fec­tive­ness? FDA ex­plains in new draft guid­ance

Last year

Sen­a­tors press De­part­ment of De­fense on over­re­liance on for­eign drug man­u­fac­tur­ers

Last year
Pharma
Manufacturing

FDA pro­pos­es tight­en­ing re­stric­tions on com­pound­ing three cat­e­gories of drugs

Last year
Pharma

Up­dat­ed: FDA ex­pands la­bel for nasal spray to treat chron­ic si­nus in­flam­ma­tion

Last year
Pharma

FDA green­lights Or­chard's gene ther­a­py Len­meldy for rare and fa­tal dis­ease

Last year
Pharma
Cell/Gene Tx
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