FDA+ channel feed

Fed­er­al gov­ern­ment shut­down watch: FDA and in­dus­try prep for like­ly clo­sure Oct. 1

Last year
Pharma

Take­da wins FDA ap­proval for self-ad­min­is­tered, sub­cu­ta­neous En­tyvio in ul­cer­a­tive col­i­tis

Last year

FDA ap­proves Am­i­cus' Pom­bil­i­ti + Op­fol­da com­bo ther­a­py for Pompe dis­ease

Last year

Ad­comm rec­om­mends FDA re­ject Brain­Stor­m's ALS drug af­ter com­pa­ny filed over protest

Last year
Cell/Gene Tx

FDA ap­proves decade-old Pfiz­er drug for rare child­hood leukemia

Last year

FDA+ roundup: Agency re­opens AI dis­cus­sion pa­per for com­ments amid two-day work­shop

Last year
AI
Pharma

San­doz, Pol­phar­ma score Eu­ro­pean ap­proval for first Tysabri biosim­i­lar for mul­ti­ple scle­ro­sis

Last year

FDA re­jects Co­herus' re­worked Neu­las­ta biosim­i­lar due to third-par­ty in­spec­tions

Last year

FDA picks apart Brain­Stor­m's po­ten­tial ALS treat­ment ahead of Wednes­day ad­comm

Last year
Cell/Gene Tx

CDC ad­vi­sors rec­om­mend Pfiz­er's ma­ter­nal RSV vac­cine in 11-1 vote

Last year
Pharma

Boehringer In­gel­heim, Eli Lil­ly clinch new FDA ap­proval for block­buster Jar­diance to treat chron­ic kid­ney dis­ease

Last year
Pharma

FDA ad­vi­sors unan­i­mous­ly re­ject Intar­ci­a's em­bat­tled type 2 di­a­betes treat­ment

Last year
Pharma

In new draft guid­ance for man­u­fac­tur­ing in­spec­tions, FDA draws in­spi­ra­tion from pan­dem­ic meth­ods

Last year
Manufacturing

Elon Musk's brain-com­put­er pro­gram be­gins re­cruit­ing paral­y­sis pa­tients

Last year
R&D
Pharma

FDA wants to know: What's hold­ing up the de­vel­op­ment of in­di­vid­u­al­ized cell and gene ther­a­pies?

Last year
Cell/Gene Tx

FDA un­der­scores qual­i­ty, safe­ty con­cerns with Intar­cia’s di­a­betes treat­ment ahead of ad­comm

Last year
Pharma

UCB's Eu­rope-ap­proved IL-17 au­toim­mune drug hits FDA de­lay

Last year
R&D

FDA re­jects first nasal spray al­ter­na­tive to EpiPen for those with se­vere al­ler­gies

Last year

Chi­nese im­ports of com­mon can­cer drug run dry, FDA says

Last year
Manufacturing

House law­mak­ers press CMS on mon­i­tor­ing re­bate in­for­ma­tion, tout PBM re­forms at hear­ing

Last year
Pharma

No­var­tis hands back PD-1 in­hibitor to BeiGene af­ter reg­u­la­to­ry hur­dles

Last year
Deals
R&D

FDA of­fers more guid­ance on re­ly­ing on just one tri­al and con­fir­ma­to­ry ev­i­dence for a new drug ap­proval

Last year

CDER di­rec­tor urges man­u­fac­tur­ers to work with FDA to fix in­spec­tion is­sues be­fore shut­ting down

Last year
Pharma
Manufacturing

Plat­form des­ig­na­tions: FDA's new cell and gene ther­a­py su­per of­fice di­rec­tor sees po­ten­tial

Last year
Cell/Gene Tx
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