FDA+ channel feed

Blue­bird shares tank af­ter FDA puts an­oth­er hold on its long de­layed sick­le cell gene ther­a­py

4 years ago
R&D

Ar­genx touts first-in-class win for a rare dis­ease that caus­es life-threat­en­ing mus­cle weak­ness

4 years ago

Deal­ing Bio­gen an­oth­er blow, EMA rec­om­mends re­ject­ing Aduhelm in three terse para­graphs

4 years ago

FDA per­ma­nent­ly lifts in-per­son re­quire­ments for dis­pens­ing abor­tion pills

4 years ago

Un­co­or­di­nat­ed and re­dun­dant: FDA's Paz­dur slams check­point in­hibitor de­vel­op­ers for cre­at­ing a 'Wild West'

4 years ago
R&D
China

Cal­lid­i­tas nabs ac­cel­er­at­ed OK for rare kid­ney dis­ease, beat­ing two com­peti­tors to the punch

4 years ago

FDA seeks FTC ac­tion af­ter re­ject­ing pe­ti­tion to block first gener­ics for decades-old va­so­pressin

4 years ago
Pharma

Bio­gen re­veals plans for con­fir­ma­to­ry Aduhelm study, promis­ing re­sults in 5 years

4 years ago
R&D

Op-ed: 5 un­set­tled is­sues a Califf-run FDA will need to tack­le in 2022 and be­yond

4 years ago

Amid safe­ty con­cerns, FDA grants two new JAK ap­provals — but with added warn­ings and a key la­bel change

4 years ago

Sen­ate health com­mit­tee again of­fers its sup­port for FDA com­mis­sion­er nom­i­nee Rob Califf

4 years ago

Genen­tech's tocilizum­ab short­age due to Covid-19 now hits CAR-T re­cip­i­ents, with FDA of­fer­ing al­ter­na­tives to help

4 years ago
Coronavirus

FDA ad­comm votes unan­i­mous­ly against Reata's po­ten­tial Al­port syn­drome treat­ment

4 years ago
R&D

Of­fer­ing a long-await­ed op­tion for the un­vac­ci­nat­ed, FDA au­tho­rizes As­traZeneca's long-act­ing pre­ven­ta­tive an­ti­body

4 years ago
Coronavirus

FDA+ roundup: Re­pub­li­cans will be key for Rob Calif­f's con­fir­ma­tion; Janet Wood­cock and Mar­garet Ham­burg talk FDA and the pan­dem­ic

4 years ago

Ex-FDA chief Stephen Hahn lands an­oth­er new gig, this time as CEO of a can­cer test­ing start­up

4 years ago
Financing

FDA slams Reata's kid­ney drug as in­ef­fec­tive ahead of ad­comm meet­ing

4 years ago
Pharma

No­var­tis pe­ti­tions FDA to block 18 gener­ic com­peti­tors for its megablock­buster heart drug un­til 2024

4 years ago
Pharma

Keytru­da wins eighth FDA ap­proval of 2021, mov­ing in­to ad­ju­vant and pe­di­atric melanoma set­tings

4 years ago

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

4 years ago
R&D

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

4 years ago

Ac­cel­er­at­ed ap­proval re­forms need mean­ing­ful con­fir­ma­to­ry tri­al im­prove­ments, pro­fes­sors write in Sci­ence

4 years ago

J&J and Sanofi's mul­ti­ple myelo­ma tit-for-tat con­tin­ues, as sub­cu­ta­neous Darza­lex wins com­bo ap­proval

4 years ago

Stat­era Bio­phar­ma gets the OK to re­sume the study of a po­ten­tial stock­pile drug for lethal ra­di­a­tion ex­po­sure

4 years ago
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