FDA+ channel feed

FDA is­sues two guid­ances to ac­cel­er­ate Covid-19 treat­ments

6 years ago
Coronavirus

Blue­bird takes $200M pay­out from Bris­tol My­ers as Covid-19, BLA de­lays force ex­ecs to bring out the bud­get ax

6 years ago
Deals

De­railed by the pan­dem­ic, FDA of­fers CRISPR, Ver­tex drug pro­gram VIP sta­tus for its come­back play

6 years ago
R&D

As­traZeneca, Mer­ck­'s star PARP in­hibitor Lyn­parza ex­pands reach in ovar­i­an can­cer with new US ap­proval

6 years ago
Pharma

A ground­break­ing can­cer drug nabs fast OK, giv­ing Eli Lil­ly boast­ing rights as a ri­val speeds close be­hind

6 years ago
R&D

FDA is­n't lift­ing the clin­i­cal hold on Sol­id Bio's Duchenne MD gene ther­a­py just yet — but is there a sil­ver lin­ing?

6 years ago
Cell/Gene Tx

CDER re­leas­es pol­i­cy for han­dling new­ly iden­ti­fied safe­ty sig­nals

6 years ago

No­var­tis lands cap­ma­tinib ap­proval, giv­ing them a sec­ond po­ten­tial block­buster from In­cyte

6 years ago
Pharma

As­traZeneca's block­buster Farx­i­ga se­cures land­mark ap­proval in heart fail­ure pa­tients, re­gard­less of whether they have di­a­betes

6 years ago
R&D

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
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