Regulatory channel feed

Drug-drug in­ter­ac­tions: FDA is­sues guid­ance on clin­i­cal, in vit­ro stud­ies

53 minutes ago
Pharma
Regulatory

FDA waves Epizyme's $186K rare can­cer drug through to mar­ket — now get ready for the sec­ond act

1 hour ago
Pharma
Regulatory

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

23 hours ago
Bioregnum
Regulatory

NICE stays sour on As­traZeneca's Tagris­so

2 days ago
Regulatory

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. ...

2 days ago
Regulatory

UP­DAT­ED: FDA hands off its lat­est whirl­wind drug OK as Hori­zon hus­tles would-be block­buster to the mar­ket

2 days ago
Pharma
Regulatory

FDA to al­low on­line sub­mis­sions of or­phan des­ig­na­tion re­quests

3 days ago
Regulatory

Ger­many’s IQWiG finds first tu­mor-ag­nos­tic drug pro­vides no added ben­e­fit

Last week
Regulatory

Hung ju­ry vote leaves FDA with a dif­fi­cult de­ci­sion on Durec­t's non-opi­oid painkiller

Last week
R&D
Regulatory

The FDA: Faster, but not nec­es­sar­i­ly bet­ter. And that could threat­en the agen­cy's brand

Last week
R&D
Regulatory

Bio­phar­ma's Chi­na plan gets a boost from patent pro­tec­tions sealed in now of­fi­cial trade deal

Last week
China
Regulatory

Gov­ern­ment spend­ing bill tweak means 3 more NDAs will be­come BLAs, FDA says

Last week
Regulatory

FDA staff high­lights neu­ro­log­i­cal safe­ty con­cerns with Durec­t's pain drug

Last week
Regulatory

UK's NICE is­n't con­vinced by Mer­ck­'s Keytru­da in head and neck can­cer

Last week
Regulatory

‘Clin­i­cal su­pe­ri­or­i­ty’: di­azepam nasal spray il­lus­trates FDA pa­ra­me­ters for or­phan drug ex­clu­siv­i­ty

Last week
R&D
Regulatory

Blue­print scores first FDA OK for a pre­ci­sion GIST can­cer drug, just ahead of a ri­val treat­ment. And the price is a ...

2 weeks ago
Pharma
Regulatory

Mer­ck­'s Keytru­da wins an­oth­er first — this time for an FDA nod to treat a sub­set of blad­der can­cer pa­tients

3 weeks ago
Pharma
Regulatory

'Burn­er' phones and Ari­ad se­crets: Gold­man Sachs banker pleads guilty for his role in glob­al in­sid­er trad­ing ring

3 weeks ago
People
Regulatory

FDA of­fers As­traZeneca a short­cut on a land­mark SGLT2 ap­proval while Chi­na green­lights Lokel­ma

3 weeks ago
Pharma
Regulatory

FDA rushed to ap­prove new drugs in 2019, some­times way ahead of sched­ule. Could that be dan­ger­ous?

3 weeks ago
Regulatory

Clin­i­cal un­cer­tain­ty, price push­es UK's NICE to spurn Akcea's Waylivra

3 weeks ago
Regulatory

Chi­na green­lights home­grown pneu­mo­coc­cal, HPV vac­cines for the mar­ket — break­ing grips by Pfiz­er, Mer­ck

3 weeks ago
China
Regulatory

Savara gets FDA break­through sta­tus de­spite large, late-stage fail­ure

4 weeks ago
R&D
Regulatory

As Bris­tol-My­ers, Pfiz­er bat­tle copy­cat chal­lengers in court, FDA ap­proves gener­ics for block­buster Eliquis

Last month
Regulatory
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