FDA+ channel feed

FDA slaps a hold on Log­icBio and its gene edit­ing plans — shares tum­ble

6 years ago
Cell/Gene Tx

Are pri­or­i­ty re­view vouch­er pro­grams stim­u­lat­ing drug de­vel­op­ment? The da­ta sug­gest not re­al­ly, finds GAO re­port

6 years ago
R&D

End­ing four years of le­gal fight, ARCH-backed syn­thet­ic DNA mak­er set­tles law­suit with CEO's for­mer em­ploy­er

6 years ago

FDA tar­gets faster re­views for biosim­i­lar sup­ple­ments, draft guid­ance says

6 years ago

EMA, FDA and WHO prep for new coro­n­avirus treat­ments, IVDs

6 years ago
R&D
Coronavirus

Too slow to warn: Sanofi in­dict­ed over old an­ti-epilep­tic drug tied to birth de­fects

6 years ago
Pharma

Court sides with FDA in Van­da clin­i­cal hold suit

6 years ago

GAO re­port rais­es ques­tions about reau­tho­riz­ing two PRV pro­grams

6 years ago

Aim­mune wins ap­proval for peanut im­munother­a­py, charges 10k+

6 years ago
Pharma

Hahn stress­es im­por­tance of da­ta, RWE in first all-hands meet­ing

6 years ago

FDA out­lines prod­uct de­vel­op­ment process to com­bat Wuhan coro­n­avirus

6 years ago
Coronavirus

What in the world is a MI­NOR CRL, Am­phastar?

6 years ago
R&D

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

6 years ago
People

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

6 years ago
Pharma

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

6 years ago
Pharma

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

6 years ago
Bioregnum
Opinion

NICE stays sour on As­traZeneca's Tagris­so

6 years ago

FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

6 years ago

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

6 years ago
Pharma

FDA to al­low on­line sub­mis­sions of or­phan des­ig­na­tion re­quests

6 years ago

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

6 years ago

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

6 years ago
R&D

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

6 years ago
R&D

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

6 years ago
China
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