FDA+ channel feed

FDA is­sues sec­ond CRL to Su­per­nus for Parkin­son's drug-de­vice com­bo

Last year

FDA ap­proves J&J and Leg­end’s Carvyk­ti for sec­ond-line mul­ti­ple myelo­ma

Last year
Pharma
Cell/Gene Tx

FDA grants En­her­tu tu­mor-ag­nos­tic ac­cel­er­at­ed ap­proval

Last year
Pharma

Loos­en­ing Med­ic­aid re­stric­tions on hep C drugs could im­prove pa­tient ac­cess, study finds

Last year
Pharma

Bris­tol My­ers and 2sev­en­ty win la­bel ex­pan­sion for Abec­ma in ear­li­er mul­ti­ple myelo­ma

Last year
Pharma

Paxlovid didn’t short­en Covid symp­toms in vac­ci­nat­ed adults, full tri­al re­sults con­firm

Last year
Pharma
Coronavirus

FDA ap­proves Basilea’s an­tibi­ot­ic for se­vere bac­te­r­i­al in­fec­tions

Last year
Pharma

WuXi builds out lob­by­ing bench amid leg­isla­tive ef­fort to black­list com­pa­ny

Last year
China
Pharma

'We beat big phar­ma': Biden ap­plauds IRA, calls for ex­pan­sion of Medicare ne­go­ti­a­tions

Last year
Pharma

Al­most all dos­es of Moun­jaro, Zep­bound in short sup­ply through Q2

Last year
Pharma

Con­gress' Chi­na hawks seek to add biotech sup­pli­ers to Pen­ta­gon warn­ing list

Last year
China

CBER's Marks points to stock­piles of H5N1 vac­cine as of­fi­cials mon­i­tor re­port­ed hu­man case

Last year
Pharma

BM­S' con­fir­ma­to­ry tri­al of Kraza­ti hits pri­ma­ry end­point fol­low­ing 2022 ac­cel­er­at­ed ap­proval

Last year
Pharma

FDA de­lays de­ci­sion on Ap­plied Ther­a­peu­tics’ rare meta­bol­ic dis­ease drug

Last year

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
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