FDA+ channel feed

Com­pa­nies ask FDA for reg­u­la­tion, im­prove­ment of da­ta col­lec­tion from dig­i­tal health de­vices

Last year
Pharma

FDA warns Sure-BioChem over qual­i­ty and da­ta is­sues

Last year
Pharma
Manufacturing

FDA grants an ex­pand­ed Ay­vak­it la­bel to Blue­print Med­i­cines

Last year

FDA ap­proves an­oth­er new type of opi­oid over­dose an­ti­dote nasal spray

Last year

Gov­ern­ment-backed pi­lots in­ves­ti­gate how tech can bet­ter se­cure the drug sup­ply chain

Last year
Pharma
Manufacturing

FDA plans to on­ly is­sue pe­di­atric ex­clu­siv­i­ty for new stud­ies — not just those re­quired un­der PREA

Last year

Up­dat­ed: In an­oth­er blow for NASH, FDA ad­comm op­pos­es ac­cel­er­at­ed ap­proval of In­ter­cept drug

Last year

First-of-its-kind gene ther­a­py ap­proved for heal­ing wounds in “but­ter­fly chil­dren”

Last year
R&D
Cell/Gene Tx

Ab­b­Vie, Gen­mab land FDA OK for CD3xCD20 bis­pe­cif­ic, catch­ing up with Roche

Last year

CBER chief Pe­ter Marks to con­sid­er 'al­ter­na­tives' to clin­i­cal holds as they 'put shud­ders down in­vestors' spines'

Last year
Cell/Gene Tx

Bausch + Lomb and No­valiq win ap­proval for dry eye dis­ease treat­ment

Last year
Pharma

Ab­b­Vie nabs sev­enth FDA ap­proval for Rin­voq, adds Crohn’s dis­ease in­di­ca­tion

Last year
Pharma
Marketing

CDER lead­ers ready to im­ple­ment swifter ac­cel­er­at­ed ap­proval with­draw­al process

Last year

In­ter­cep­t's NASH hope­ful gets pre­lim­i­nary thumbs down in FDA brief­ing docs

Last year
R&D

Mer­ck de­fends an­tibi­otic's ap­proval from 2019 as BMJ in­ves­ti­ga­tion points to 'de­cline' in FDA stan­dards

Last year

Pri­or­i­ty re­view for Take­da’s ul­tra-rare blood clot ERT; FDA to give an­oth­er look at Arde­lyx’s CKD drug

Last year
News Briefing

Ex-FDA neu­ro chief Bil­ly Dunn is tak­ing a spin through the re­volv­ing door with bio­phar­ma — and that's a prob­lem

Last year
Bioregnum

FDA ap­proves Al­ler­gan's newest hyaluron­ic acid in­jectable — with a new de­liv­ery sys­tem

Last year
Pharma

FDA sig­nals sup­port for Pfiz­er’s RSV shot in ad­comm docs be­fore cru­cial vote

Last year
Pharma

$97M gene ther­a­py con­sor­tium aims to give com­pa­nies and rare dis­ease fam­i­lies a ‘north star’

Last year
R&D

FDA is­sues CRL to small Dutch biotech's breast can­cer ADC as OS fig­ures fail to im­press

Last year

FDA ad­comm backs ac­cel­er­at­ed ap­proval of Sarep­ta's Duchenne gene ther­a­py in close vote

3 years ago
R&D
Pharma

Astel­las wins ap­proval for menopause hot flash treat­ment Veozah

3 years ago
Pharma

Law­mak­ers call on FDA to cre­ate more uni­for­mi­ty in rare dis­ease drug re­views

3 years ago
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