FDA+ channel feed

A risky bet on a long-de­layed CAR-T drug now faces a do-or-die dead­line — where any slip can kill a $9 CVR

6 years ago
R&D

Bat­tling low ex­pec­ta­tions and go­liath ri­vals, Re­gen­eron/Sanofi add pos­i­tive Lib­tayo da­ta in pur­suit of block­buster sta­tus

6 years ago
R&D

FDA cre­ates um­brel­la emer­gency path­way for Covid-19 serol­o­gy tests

6 years ago
Coronavirus

FDA cheers on Gilead­'s remde­sivir with a snap emer­gency OK, giv­ing bio­phar­ma a shot at re­demp­tion

6 years ago
R&D
Coronavirus

Bris­tol My­ers Squibb gets pri­or­i­ty re­view for AML drug as list of po­ten­tial Cel­gene hits length­ens

6 years ago
R&D

Com­mer­cial strat­e­gy for Gilead­'s Covid-19 drug-to-be remde­sivir re­mains opaque, as chief O'­Day em­pha­sizes re­spon­si­bil­i­ty

6 years ago
R&D
Pharma

Af­ter NIH tri­al, EMA be­gins rolling re­view for remde­sivir, set­ting up po­ten­tial au­tho­riza­tions in US and Eu­rope

6 years ago
R&D
Coronavirus

GSK widens the mar­ket for Ze­ju­la as FDA signs off on the PARP in­hibitor for use in ovar­i­an can­cer pa­tients with­out BR­CA mu­ta­tions

6 years ago
Pharma

FDA, EU au­thor­i­ties up­date guid­ance on clin­i­cal tri­als dur­ing Covid-19

6 years ago
Coronavirus

Bank­ing on hope, swayed by hype? Hy­drox­y­chloro­quine in the time of Covid-19

6 years ago
Coronavirus
In Focus

Ver­tex's cys­tic fi­bro­sis drugs work, but they're too ex­pen­sive, ICER finds

6 years ago
Pharma

Weeks af­ter FDA de­lay, Roche, PTC un­veil an­oth­er batch of pos­i­tive ris­diplam da­ta in se­vere SMA pa­tients

6 years ago
R&D

FDA warns on safe­ty threat posed by 2 drugs ini­tial­ly backed by Trump for Covid-19 — fol­low­ing an emer­gency use au­tho­riza­tion

6 years ago
Coronavirus

FDA al­lows com­pounders to repack­age, com­bine propo­fol amid Covid-19

6 years ago
Coronavirus

Over a year af­ter re­jec­tion, Im­munomedics emerges with po­ten­tial block­buster ap­proval

6 years ago
Pharma

Ab­b­Vie, J&J block­buster Im­bru­vi­ca rakes in 11th FDA ap­proval, as com­peti­tors work on erod­ing fran­chise

6 years ago
R&D
Pharma

EMA up­dates on reg­u­la­to­ry ex­pec­ta­tions amid Covid-19

6 years ago
Coronavirus

In­cyte nabs 2nd ever ap­proval ahead of sched­ule as FDA in­sists it can still re­view on time

6 years ago
Pharma

With third FDA ap­proval, Seat­tle Ge­net­ics plans vir­tu­al launch of metasta­t­ic breast can­cer drug amid coro­n­avirus pan­dem­ic

6 years ago
Pharma

Covid-19 vac­cine track­er up­dat­ed to in­clude GSK/Sanofi col­lab­o­ra­tion

6 years ago
Coronavirus

Har­vard profs main­tain that the FDA's re­cent ac­tions on Covid-19 de­val­ue the gold stan­dard and threat­en pub­lic trust

6 years ago
Coronavirus

FDA stamps OK on Uro­Gen's chemo gel — putting Liz Bar­rett and team's com­mer­cial chops to test amid pan­dem­ic

6 years ago
Pharma

FDA of­fers guid­ance for gener­ic drug de­vel­op­ers of hy­drox­y­chloro­quine, chloro­quine

6 years ago
Coronavirus

FDA re­ports more short­ages of drugs used to put Covid-19 pa­tients on ven­ti­la­tors

6 years ago
Coronavirus
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