FDA+ channel feed

UK fol­lic­u­lar lym­phoma pa­tients set to get non-chemother­a­py ther­a­py as NICE backs Revlim­id com­bo

6 years ago

Aca­cia Phar­ma's twice spurned drug fi­nal­ly makes the FDA cut

6 years ago
R&D

FDA mon­i­tor­ing 20 drugs at risk of short­age due to coro­n­avirus

6 years ago
China
Coronavirus

Clin­i­cal tri­al spon­sors have to dis­close decade’s worth of un­re­leased da­ta, fed­er­al judge rules

6 years ago

In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

6 years ago

FDA launch­es search­able Pur­ple Book

6 years ago

No­var­tis' plans to wres­tle Eylea mar­ket share take a hit as Beovu is linked to safe­ty con­cerns

6 years ago
Pharma

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

6 years ago

Drug ap­provals: FDA pub­lish­es dataset of CDER ap­provals since 1985

6 years ago

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
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