FDA+ channel feed

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

3 years ago
Deals
Pharma

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

3 years ago

UK reg­u­la­tor warns of se­vere eye re­ac­tions fol­low­ing use of Sanofi and Re­gen­eron's Dupix­ent

3 years ago

Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

3 years ago
Pharma

FDA re­jects Cri­net­ic­s' cur­rent PhII de­sign for hy­per­in­sulin­ism drug

3 years ago

Up­dat­ed: Roche pulls PD-L1 block­buster's ac­cel­er­at­ed ap­proval in blad­der can­cer

3 years ago
Pharma

In­dus­try groups, CVS pick apart FDA's pro­posed path­way for gener­ics to carve out OTC in­di­ca­tions

3 years ago

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

3 years ago
R&D

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

3 years ago

Sus­pend­ed Cal­i­for­nia cell ther­a­py man­u­fac­tur­ing site hit with FDA warn­ing let­ter over ma­jor qual­i­ty con­cerns

3 years ago
Pharma
Manufacturing

FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

3 years ago
Pharma

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

3 years ago
Cell/Gene Tx

The ac­cel­er­at­ed ap­proval path­way is evolv­ing in plain sight, with or with­out con­gres­sion­al help

3 years ago

Days af­ter re­port­ing PhI­II fail­ure, GSK pulls BC­MA drug from US mar­ket — but it's not giv­ing up en­tire­ly yet

3 years ago
Pharma

An­ti-abor­tion groups file suit against FDA in Texas, de­mands agency re­voke ap­proval for abor­tion pill

3 years ago
Law

FDA hits Io­vance with one more de­lay for TIL ther­a­py, ex­tend­ing BLA fil­ing un­til 2023

3 years ago
Cell/Gene Tx

Up­dat­ed: Proven­tion prices drug to de­lay type I di­a­betes at $193K as FDA nod kicks off US launch with Sanofi

3 years ago

Take­da touts pos­i­tive first-line leukemia re­sults — but is­n't quite ready to re­veal the hard da­ta

3 years ago
Pharma

Lil­ly wins FDA ap­proval for sec­ond in­ter­change­able in­sulin biosim­i­lar

3 years ago
Pharma

FDA lead­ers Califf and Paz­dur dish on ac­cel­er­at­ed ap­proval re­forms, sin­gle-coun­try tri­als and an emp­ty White Oak

3 years ago

Up­dat­ed: In sur­prise turn, FDA ad­comm votes in fa­vor of Arde­lyx CKD drug de­spite agency ques­tions

3 years ago
Pharma

UK cost watch­dog drafts guid­ance against 5 Covid treat­ments and J&J de­pres­sion med

3 years ago
Pharma
Coronavirus

Biden looks for $9B+ in new Covid funds as Sen­ate pass­es res­o­lu­tion to end emer­gency de­c­la­ra­tion

3 years ago
Coronavirus

FDA con­tin­ues to ques­tion Arde­lyx CKD drug's ef­fect on clin­i­cal out­comes ahead of ad­comm meet­ing

3 years ago
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