FDA+ channel feed

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

Last week
Deals
R&D

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

Last week

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

Last week
Pharma
Manufacturing

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

Last week
Cell/Gene Tx

EMA gives thumbs-down to GSK's mul­ti­ple myelo­ma drug, PTC's Duchenne can­di­date

3 weeks ago
Pharma

FDA re­vers­es, plans to pull in­ter­change­abil­i­ty state­ment from la­bels of in­ter­change­able biosim­i­lars

3 weeks ago

Not 'TIL' 2024: Io­vance’s li­fileu­cel faces yet an­oth­er ap­proval de­lay, this time due to FDA re­source con­straints

3 weeks ago
Cell/Gene Tx

House De­moc­rats push back on Re­pub­li­cans’ drug short­age pro­pos­als dur­ing leg­isla­tive hear­ing

3 weeks ago
Pharma

CMS re­veals 34 Medicare drugs sub­ject to in­fla­tion re­bates un­der IRA next quar­ter

3 weeks ago
Pharma

FDA ad­comm votes in fa­vor of Al­ny­lam's new in­di­ca­tion for On­pat­tro

3 weeks ago

CDER chal­lenges On­copep­tides’ ap­peal over Pepax­to with­draw­al

3 weeks ago
Pharma

FDA makes some strides in eas­ing US can­cer drug sup­ply short­ages by work­ing with man­u­fac­tur­ers

3 weeks ago
Manufacturing

HHS says Mer­ck­'s in­ter­pre­ta­tions of IRA 'doom' its le­gal chal­lenge

3 weeks ago
Pharma
Law

FDA sets spring de­ci­sion date for Madri­gal’s NASH treat­ment, days af­ter com­pa­ny an­nounced new CEO

3 weeks ago
R&D

Rock­et Phar­ma­ceu­ti­cals says FDA agrees to 12-pa­tient study for ac­cel­er­at­ed ap­proval, ex­pects to raise $175M

3 weeks ago
Financing

White House warns over lack­lus­ter FDA fund­ing in­crease in in­com­ing ap­pro­pri­a­tions bill

3 weeks ago
Law

CDC pan­el rec­om­mends up­dat­ed Covid boost­ers for peo­ple 6 months and old­er

3 weeks ago
Pharma

'A done deal': FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly against ef­fi­ca­cy da­ta for OTC nasal de­con­ges­tant

3 weeks ago
Pharma

Am­gen's Leah Christl makes the case to keep the in­ter­change­abil­i­ty des­ig­na­tion for biosim­i­lars

3 weeks ago

FDA slaps CVS, Wal­greens and oth­ers with warn­ing let­ters for un­ap­proved eye treat­ments

3 weeks ago
Pharma

No­var­tis is­sues vol­un­tary re­call of oral cy­closporine Sandim­mune due to crys­tal­liza­tion con­cerns

3 weeks ago
Manufacturing

Roche to re­file sub­cu­ta­neous Tecen­triq ap­pli­ca­tion with FDA be­fore year’s end on the back of man­u­fac­tur­ing tweaks

3 weeks ago
Manufacturing

Bi­o­Lin­eRx’s Aphex­da ap­proved to aid stem cell trans­plants for mul­ti­ple myelo­ma pa­tients

3 weeks ago
Pharma

FDA green­lights up­dat­ed Covid shots, mak­ing fall boost­er roll­out im­mi­nent

3 weeks ago
Pharma
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