FDA+ channel feed

J&J pitch­es its S1P1 MS drug in­to the reg­u­la­to­ry ring as the com­pe­ti­tion heats up fast

6 years ago
R&D

FDA un­veils guid­ance for Covid-19 tri­als

6 years ago
Coronavirus

Con­tract man­u­fac­tur­er: FDA has halt­ed do­mes­tic phar­ma in­spec­tions

6 years ago
Coronavirus

FDA of­fers Roche an emer­gency OK for coro­n­avirus test­ing tech — eas­ing a crit­i­cal log­jam

6 years ago
Coronavirus

Taint­ed do­na­tions from stool bank reignite safe­ty con­cerns about poop trans­plants

6 years ago
R&D

A one-time biotech uni­corn gets slaugh­tered as lead pro­gram is scrapped, high­light­ing lin­ger­ing trou­ble

6 years ago
R&D

Coro­n­avirus: WHO de­clares pan­dem­ic, EMA meet­ings go vir­tu­al

6 years ago

FDA drafts guid­ance on al­ter­nate elec­tron­ic for­mats, an­nounces sup­port for new da­ta stan­dards

6 years ago

Af­ter hit­ting big in mul­ti­ple myelo­ma, J&J, Gen­mab now have a new 'break­through' in NSCLC to boast about

6 years ago

Tiny Treve­na re­turns to FDA in sec­ond bid for con­tro­ver­sial opi­oid painkiller

6 years ago

FDA re­quires boxed warn­ing for Sin­gu­lair and its gener­ics

6 years ago
Pharma

In­di­vid­u­al­ized ther­a­pies: CBER di­rec­tor dis­cuss­es chal­lenges, reg­u­la­to­ry ap­proach

6 years ago

Why FDA can’t dis­close the first coro­n­avirus-re­lat­ed drug short­age

6 years ago
Pharma
Coronavirus

An­oth­er hic­cup for GW Phar­ma's seizure drug ri­val, as Zo­genix dis­clos­es FDA re­view de­lay

6 years ago

FDA taps chemora­dio-sen­si­tiz­ing head and neck can­cer drug as 'break­through'

6 years ago

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
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