Regulatory channel feed

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

2 days ago
R&D
Regulatory

Ver­tex deal for Scot­land — no deal for Eng­land

2 days ago
Pharma
Regulatory

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

5 days ago
Regulatory

No­var­tis makes new da­ta in­tegri­ty com­mit­ment

6 days ago
Regulatory

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

6 days ago
Pharma
Regulatory

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

Last week
People
Regulatory

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

Last week
R&D
Regulatory

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

Last week
R&D
Regulatory

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

Last week
Regulatory
Startups

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

Last week
People
Regulatory

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

Last week
Pharma
Regulatory

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

3 weeks ago
People
Regulatory

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

3 weeks ago
Regulatory

FDA fi­nal­izes guid­ance on place­bos and blind­ing for can­cer tri­als

3 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

3 weeks ago
Regulatory

Bris­tol-My­ers, Ab­b­Vie's mul­ti­ple myelo­ma drug wins sec­ond EU nod as part of triple reg­i­men

3 weeks ago
Pharma
Regulatory

Decades in the mak­ing, Ky­owa Hakko Kirin fi­nal­ly wins FDA ap­proval for add-on Parkin­son's ther­a­py

3 weeks ago
Pharma
Regulatory

FDA to roll out mod­ern­iza­tion plan in push for da­ta in­ter­op­er­abil­i­ty

3 weeks ago
Regulatory

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

4 weeks ago
Pharma
R&D

Clear­side Bio­med­ical pre­dicts its uveitis drug will be re­ject­ed, af­ter FDA re­quests more da­ta

4 weeks ago
R&D
Regulatory

Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

4 weeks ago
Regulatory

Sir An­drew Dil­lon, NICE's first — and on­ly — chief ex­ec­u­tive to step down next year

4 weeks ago
People
Pharma

Finch grabs a $53M round de­signed to take their ‘break­through’ mi­cro­bio­me treat­ment through a po­ten­tial­ly piv­otal ...

4 weeks ago
Regulatory
Startups

SEC calls out lit­tle Ther­a­peu­tic­sMD for its in­sid­er con­tacts with an­a­lysts to boost share price, then halt rout

4 weeks ago
Regulatory
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