FDA+ channel feed

FDA re­jects Stealth's rare dis­ease drug, but of­fers po­ten­tial for ac­cel­er­at­ed ap­proval

18 hours ago
Manufacturing

The fate of Mod­er­na’s next-gen Covid shot looms large af­ter a flur­ry of pol­i­cy changes

Yesterday
R&D

FDA lead­er­ship preps for sum­mer bio­phar­ma lis­ten­ing tour across six cities

2 days ago

FDA re­jects Savara’s rare lung dis­ease drug over lim­it­ed man­u­fac­tur­ing da­ta

2 days ago
Pharma
Manufacturing

RFK Jr. ends an­nu­al Covid vac­cine rec­om­men­da­tions for kids, preg­nant women

2 days ago

Liq­uidia wins ap­proval for in­haled hy­per­ten­sion drug in two set­tings, fur­ther­ing ri­val­ry with Unit­ed Ther­a­peu­tics

2 days ago
Pharma

Up­dat­ed: Pa­tient dies in Rock­et gene ther­a­py tri­al, which is put on clin­i­cal hold by FDA

2 days ago
Cell/Gene Tx

About 5% of CBER and CDER left af­ter FDA staff cuts, analy­sis finds

6 days ago
People

CHMP clears path for GSK’s Blenrep re­launch, rec­om­mends four oth­er drugs 

6 days ago
Pharma

Fed­er­al judge ex­tends or­der block­ing RFK Jr. from re­or­ga­niz­ing HHS

6 days ago
Law

GSK’s Nu­cala wins COPD ap­proval, stok­ing ri­val­ry with Dupix­ent 

Last week
Pharma

Up­dat­ed: FDA ex­pects 'time­ly avail­abil­i­ty' of Covid shots as ad­vi­sors up­date for­mu­la rec­om­men­da­tion

Last week
Coronavirus

FDA chief to sen­a­tors: 3,000+ staff de­par­tures won't de­lay user fee tar­gets

Last week

The ‘MA­HA re­port’: Four key take­aways on vac­cines, med­i­cine and the phar­ma in­dus­try

Last week
Pharma

FDA ad­comm votes unan­i­mous­ly against Pfiz­er's prostate can­cer drug com­bo

Last week
Pharma

FDA asks Covid vac­cine mak­ers to add more my­ocardi­tis da­ta to la­bels

Last week
Pharma

FDA an­nounces ef­forts to fa­cil­i­tate drug im­por­ta­tion from Cana­da 

Last week
Pharma
Manufacturing

FDA ad­comm nar­row­ly votes against Uro­Gen’s blad­der can­cer drug, calls for RCTs

Last week
Pharma

In his first ma­jor pol­i­cy roll­out, Vinay Prasad looks to chal­lenge ex­ist­ing 'dog­ma' on Covid vac­cines

Last week
R&D

Up­dat­ed: FDA ad­comm splits votes on Genen­tech and J&J can­cer drugs

Last week

RFK Jr. spars with sen­a­tors over re­search cuts, HHS bud­get plan

Last week
Pharma

Makary, Prasad spell out FDA ground rules for fu­ture Covid vac­cine ap­provals

Last week
Coronavirus

Up­dat­ed: FDA ap­proves No­vavax's Covid vac­cine af­ter six-week de­lay, but for a small­er pop­u­la­tion

Last week
Pharma

Sarep­ta seeks to ex­pand Duchenne gene ther­a­py Ele­v­idys use to tod­dlers

Last week
R&D
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