FDA+ channel feed

EMA con­sid­ers se­ri­ous eye con­di­tion a ‘very rare’ side ef­fect of semaglu­tide 

Last month
Pharma

FDA's Makary looks at ways to speed drug ap­provals, talks about cut­ting user fees

Last month
Cell/Gene Tx

Trump's health ap­pointees pledge sup­port for cell and gene ther­a­pies at FDA round­table

Last month
Cell/Gene Tx

FDA's Prasad ex­plains ra­tio­nale be­hind paus­ing Val­neva's chikun­gun­ya vac­cine in se­niors

Last month

In a first, Sarep­ta an­nounces plat­form tech­nol­o­gy des­ig­na­tion for gene ther­a­py vec­tor

Last month
Cell/Gene Tx

New CBER chief Prasad promis­es to 'rapid­ly' push even small ad­vances for rare dis­ease drugs

Last month

FDA's 2026 bud­get plan seeks to shrink over­all funds, but in­crease user fees

Last month

DOGE set to­day as their last day at FDA. In­stead, they're con­tin­u­ing to get full pay and don't work

Last month
People

FDA ap­proves Mod­er­na’s next-gen Covid vac­cine, with lim­its on most healthy peo­ple

Last month
Pharma

HHS says it's pulled Covid shot guid­ance for healthy kids. The CDC vac­cine sched­ule shows oth­er­wise

Last month
Pharma

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

Last month
Manufacturing

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

Last month
R&D

FDA lead­er­ship preps for sum­mer bio­phar­ma lis­ten­ing tour across six cities

Last month

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

Last month
Pharma
Manufacturing

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

Last month

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

Last month
Pharma

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

Last month
Cell/Gene Tx

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

Last month
People

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

Last month
Pharma

Fed­er­al judge ex­tends or­der block­ing RFK Jr. from re­or­ga­niz­ing HHS

Last month
Law

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

Last month
Pharma

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

Last month
Coronavirus

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

Last month

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

Last month
Pharma
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