FDA+ channel feed

FDA ad­comm votes in fa­vor of ARS Phar­ma­ceu­ti­cal­s' EpiPen al­ter­na­tive

3 years ago

FDA signs off on Ot­su­ka, Lund­beck­'s an­tipsy­chot­ic for Alzheimer's ag­i­ta­tion

3 years ago
Pharma

Sen­ate com­mit­tee ad­vances bi­par­ti­san PBM, FDA re­forms with eight re­lat­ed amend­ments

3 years ago
Law

FDA re­jects blad­der can­cer ther­a­py de­vel­oped by Patrick Soon-Sh­iong’s Im­mu­ni­ty­Bio

3 years ago
R&D

AI and ma­chine learn­ing: FDA spells out specifics from drug dis­cov­ery to man­u­fac­tur­ing

3 years ago
Discovery

Up­dat­ed: FDA re­port rais­es con­cerns over Sarep­ta Duchenne gene ther­a­py ahead of ac­cel­er­at­ed ap­proval de­ci­sion

3 years ago
Cell/Gene Tx

Chiesi, Pro­tal­ix's Fab­ry dis­ease treat­ment is ap­proved as Elfab­rio joins Fab­razyme, Galafold

3 years ago

As­traZeneca block­buster Farx­i­ga adds new heart in­di­ca­tion to la­bel

3 years ago
Pharma

Af­ter warn­ing let­ters and fa­tal poi­son­ings, FDA is­sues guid­ance for strin­gent test­ing of con­t­a­m­i­nants

3 years ago
Pharma
Manufacturing

DC dis­trict court sides with FDA af­ter Ipsen sued over block­buster's clas­si­fi­ca­tion as a drug

3 years ago

FDA lifts par­tial hold on Salarius' Ew­ing sar­co­ma drug tri­al

3 years ago
R&D

Eye tech com­pa­ny snags first-ever ap­proval for spray to di­late pupils for di­ag­nos­tic ex­ams

3 years ago

FDA rais­es con­cerns about la­bel com­pre­hen­sion for OTC birth con­trol pill ahead of ad­comm

3 years ago

FDA again re­quests com­ments on ni­trosamine im­pu­ri­ties in drugs

3 years ago
Manufacturing

FDA hits No­vo Nordisk with CRL for its once-dai­ly he­mo­phil­ia drug con­cizum­ab

3 years ago
Pharma

FDA cites qual­i­ty is­sues at Rentschler and Eli Lil­ly fa­cil­i­ties

3 years ago
Pharma
Manufacturing

GSK RSV shot ap­proved by FDA, start­ing next block­buster vac­cine race

3 years ago
Pharma

‘Un­be­liev­ably im­por­tant mo­ment’: Sarep­ta clears the air on man­u­fac­tur­ing, pay­ers ahead of gene ther­a­py ad­comm

3 years ago
Cell/Gene Tx

FDA ap­proves Avadel's nar­colep­sy drug af­ter courts forced Jazz patent delist­ing

3 years ago
Pharma

De­cen­tral­ized tri­als: FDA lays out its think­ing in new draft guid­ance

3 years ago
R&D

Sen­ate com­mit­tee punts on PBM re­form bill markup af­ter Re­pub­li­cans ques­tion process

3 years ago
Law

FDA hands down par­tial hold for Sun Phar­ma's alope­cia JAK can­di­date

3 years ago
Pharma

FDA re­jects As­cendis' parathy­roid can­di­date, spec­i­fy­ing man­u­fac­tur­ing con­cerns

3 years ago
Manufacturing

FDA ad­vi­so­ry com­mit­tee votes against plan for broad use of prostate can­cer drug

3 years ago
Pharma
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