FDA+ channel feed

Mallinck­rodt be­comes the lat­est vic­tim of the FDA's pan­dem­ic-re­lat­ed de­lays as it push­es off ap­pli­ca­tion for skin graft

5 years ago
Pharma
Manufacturing

Janet Wood­cock slams calls for FDA 'fire­wal­l' amid ad­u­canum­ab de­ba­cle, cit­ing need for col­lab­o­ra­tive drug de­vel­op­ment

5 years ago
People

Weeks af­ter drop­ping big re­sponse da­ta, Am­gen lines up pri­or­i­ty re­view for KRAS hope­ful so­tora­sib in NSCLC

5 years ago
Pharma

No­var­tis' En­tresto, fac­ing a big come­back in hard-to-treat heart fail­ure pa­tients, scores FDA nod af­ter ad­comm cake­walk

5 years ago
Pharma

Sesen Bio, af­ter years on the edge of ir­rel­e­van­cy, scores speedy re­view for long ges­tat­ing blad­der can­cer pro­gram

5 years ago

Up­dat­ed: Cor­texyme's un­ortho­dox Alzheimer's ap­proach tripped up by FDA hold

5 years ago

Astel­las, Seagen pave the way for Pad­cev's glob­al roll­out with full con­fir­ma­to­ry da­ta for urothe­lial can­cer in hand

5 years ago
Pharma

FDA slaps Flori­da's Al­lay Phar­ma­ceu­ti­cals with warn­ing let­ter over vague re­spons­es to drug po­ten­cy is­sues

5 years ago
Manufacturing

Am­i­cus shares slammed as lead PhI­II drug fails a key head-to-head test for Pompe dis­ease — but the CEO still projects an FDA OK and bright fu­ture

5 years ago
R&D

Re­gen­eron an­ti­body earns nod for rare cho­les­terol dis­or­der — but it ain't cheap

5 years ago

Fre­se­nius Kabi pays $50 mil­lion to set­tle crim­i­nal charges

5 years ago
Manufacturing

Ab­b­Vie adds to the Botox war chest with a 12th FDA ap­proval — but com­pe­ti­tion is fast ap­proach­ing

5 years ago

Eli Lil­ly racks up EUA for an­ti­body cock­tail — but the big­ger chal­lenge is still ahead

5 years ago
Coronavirus

With Lib­tay­o's sec­ond ap­proval, Re­gen­eron digs deep­er in­to PD-1 der­ma­to-on­col­o­gy niche

5 years ago

Free­line Ther­a­peu­tics slams the brakes on gene ther­a­py tri­al plans as FDA seeks more clar­i­ty on man­u­fac­tur­ing

5 years ago

TG Ther­a­peu­tics scores con­di­tion­al FDA go-ahead for a drug it's pitch­ing as a safer PI3K

5 years ago

Bris­tol My­ers Squibb earns long-await­ed FDA nod for liso-cel, join­ing short list of lym­phoma CAR-T win­ners

5 years ago
Pharma

FDA blasts Mer­ck­'s bid for ad­ju­vant Keytru­da in TNBC be­fore ad­comm, call­ing late-stage da­ta 'ques­tion­able'

5 years ago
Pharma

FDA slaps clin­i­cal hold on an­tibi­otics tri­al af­ter deaths in mon­key tri­al spurred con­cerns

5 years ago

PTC whiffs on an­oth­er Duchenne study, plans to go to FDA again any­way

5 years ago
R&D

FDA cites litany of er­rors at Lon­za Hous­ton plant at the cen­ter of Bris­tol My­ers CVR de­ba­cle

5 years ago
Manufacturing

Mer­ck KGaA goes toe to toe with No­var­tis as FDA green-lights MET in­hibitor

5 years ago
Pharma

Prothena re­vives its for­mer lead drug, aim­ing for a small­er pop­u­la­tion with more se­vere cas­es

5 years ago

Re­call re­port: Apo­tex re­calls 2 batch­es of blood-thin­ner in­jec­tion af­ter sy­ringe mis­la­bel­ing sna­fu

5 years ago
Manufacturing
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