FDA+ channel feed

The fourth CGRP mi­graine drug is here. Time for Lund­beck to prove it's worth $2B

6 years ago
Pharma

Es­pe­ri­on's goldilocks cho­les­terol fight­er wins FDA ap­proval — will its 'tra­di­tion­al' pric­ing ap­proach spur adop­tion?

6 years ago
Pharma

Speedy re­view and no ad­comm for Bio­Mar­in's pi­o­neer­ing he­mo­phil­ia gene ther­a­py

6 years ago
Cell/Gene Tx

Phar­ma­co­ge­net­ics: FDA re­leas­es ta­ble of gene-drug in­ter­ac­tions

6 years ago
Pharma

FDA con­sol­i­dates non­clin­i­cal im­muno­tox­i­c­i­ty eval­u­a­tion guid­ance

6 years ago

As blue­bird makes com­mer­cial progress in Eu­rope, US ap­pli­ca­tion for Zyn­te­glo suf­fers de­lay

6 years ago
Pharma

FDA goes on high alert as coro­n­avirus rais­es threat to drug man­u­fac­tur­ing and clin­i­cal tri­als grind to a halt

6 years ago
R&D
Coronavirus

In­ter­nal FDA emails re­veal how price, Sanders’ pres­sure played a role in com­peti­tor’s ap­proval, Cat­a­lyst claims

6 years ago

8 years af­ter its OK, Ei­sai yanks its flail­ing obe­si­ty drug from the mar­ket af­ter FDA flagged high­er can­cer rate

6 years ago
Pharma

De­ci­pher­a's GIST ther­a­py ripretinib wins speedy FDA re­view — set­ting the stage for bat­tle with ri­val Blue­print

6 years ago

Lil­ly, No­vo Nordisk fight in­sulin biosim­i­lars with tweaks to FDA draft guid­ance

6 years ago
Pharma

Eas­ing con­cerns, Fi­bro­Gen, As­traZeneca se­cure FDA date for their ane­mia drug in broad chron­ic kid­ney dis­ease pop­u­la­tion

6 years ago
R&D

No­var­tis nabs pri­or­i­ty re­view for a block­buster-to-be aimed at NSCLC niche — de­light­ing In­cyte ex­ecs

6 years ago

Trump’s 2021 bud­get re­quest seeks mod­est fund­ing in­crease for FDA

6 years ago

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
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