Regulatory channel feed

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

Yesterday
R&D
Regulatory

Em­maus re­scinds EU mar­ket­ing ap­pli­ca­tion, fol­low­ing neg­a­tive re­view

Yesterday
Pharma
Regulatory

FDA lays out tech mod­ern­iza­tion ac­tion plan

2 days ago
Regulatory

Pop­u­la­tion phar­ma­co­ki­net­ics: Drug­mak­ers seek clar­i­ty and ad­di­tions to re­vised FDA guid­ance

3 days ago
Pharma
Regulatory

FDA col­lab­o­rates with Health Cana­da, Aus­tralia to ap­prove new can­cer drugs

3 days ago
Regulatory

Last rites for Si­en­na, as strug­gling biotech files for Chap­ter 11

4 days ago
Regulatory

FDA ex­plains plans for new phar­ma­ceu­ti­cal qual­i­ty as­sess­ment sys­tem

4 days ago
Regulatory

Seat­tle Ge­net­ics/Astel­las win pri­or­i­ty US re­view for armed an­ti­body aimed at blad­der can­cer

5 days ago
R&D
Regulatory

EMA, FDA be­gin re­view­ing heart­burn med­i­cines for car­cino­gen

5 days ago
Regulatory

It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Last week
R&D
Regulatory

Ver­tex deal for Scot­land — no deal for Eng­land

Last week
Pharma
Regulatory

FDA de­vel­op­ing guid­ance on re­al-world da­ta qual­i­ty is­sues, of­fi­cials say

Last week
Regulatory

No­var­tis makes new da­ta in­tegri­ty com­mit­ment

Last week
Regulatory

Boehringer In­gel­heim's Ofev wins FDA ap­proval for use in scle­ro­der­ma pa­tients

Last week
Pharma
Regulatory

Stephen Hahn, 'clear fron­trun­ner' for FDA com­mish job, has met with Trump — re­ports

3 weeks ago
People
Regulatory

How much has the can­cer R&D fren­zy trans­lat­ed in­to drug ap­provals? A lot

3 weeks ago
R&D
Regulatory

A bat­tered Zaf­gen seeks strate­gic op­tions, proph­esy­ing on­go­ing study will un­like­ly lift FDA hold on di­a­betes drug

3 weeks ago
R&D
Regulatory

Strug­gling poo-test­ing start­up uBio­me files for bank­rupt­cy, months af­ter FBI kicks off in­ves­ti­ga­tion

3 weeks ago
Regulatory
Startups

Ned Sharp­less in fi­nal run­ning for FDA com­mish with MD An­der­son ex­ec and Har­vard prof — re­ports

3 weeks ago
People
Regulatory

US judge paves way for brand­ed and gener­ic opi­oid mak­ers to face land­mark Oc­to­ber tri­al

3 weeks ago
Pharma
Regulatory

Azar keen on nom­i­nat­ing Brett Giroir, di­vi­sive as­sis­tant HHS sec­re­tary, to top job at FDA — re­port

4 weeks ago
People
Regulatory

Aca­d­e­mics and re­searchers raise con­cerns with FDA’s plan for ‘in­te­grat­ed re­views’

4 weeks ago
Regulatory

FDA fi­nal­izes guid­ance on place­bos and blind­ing for can­cer tri­als

4 weeks ago
R&D
Regulatory

FDA fires off a warn­ing on rare cas­es in­volv­ing death, ad­verse liv­er events linked to mis­use of 3 big hep C drugs

4 weeks ago
Regulatory
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