Mesoblast sends in improved potency assay, looking to resubmit to FDA on acute graft-versus-host disease drug

Lei Lei Wu

News Reporter

In 2020, the FDA rejected Mesoblast’s remestemcel-L, or Ryoncil, its lead candidate for pediatric acute graft-versus-host disease (aGVHD) that didn’t respond to steroids. The …

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

BECOME A PREMIUM SUBSCRIBER

Mesoblast sends in improved potency assay, looking to resubmit to FDA on acute graft-versus-host disease drug

Lei Lei Wu

News Reporter

Sign up to read this article for free.

J&J partners on STAT6; AstraZeneca, Daiichi withdraw lung cancer drug EMA app

FDA approves subcutaneous version of Bristol Myers' Opdivo

BioNTech settles with NIH, UPenn in Covid vaccine disputes and will pay royalties

The Endpoints 2024 winners and losers list: Who was up and who was down in biopharma

WuXi AppTec will sell cell and gene therapy business to private equity firm

CMS explains what went into its first round of drug price negotiations

Mesoblast sends in im­proved po­ten­cy as­say, look­ing to re­sub­mit to FDA on acute graft-ver­sus-host dis­ease drug

Lei Lei Wu

News Reporter

Sign up to read this article for free.

more like this

J&J part­ners on STAT6; As­traZeneca, Dai­ichi with­draw lung can­cer drug EMA app

FDA ap­proves sub­cu­ta­neous ver­sion of Bris­tol My­er­s' Op­di­vo

BioN­Tech set­tles with NIH, UPenn in Covid vac­cine dis­putes and will pay roy­al­ties

The End­points 2024 win­ners and losers list: Who was up and who was down in bio­phar­ma

WuXi AppTec will sell cell and gene ther­a­py busi­ness to pri­vate eq­ui­ty firm

CMS ex­plains what went in­to its first round of drug price ne­go­ti­a­tions

Mesoblast sends in improved potency assay, looking to resubmit to FDA on acute graft-versus-host disease drug

J&J partners on STAT6; AstraZeneca, Daiichi withdraw lung cancer drug EMA app

FDA approves subcutaneous version of Bristol Myers' Opdivo

BioNTech settles with NIH, UPenn in Covid vaccine disputes and will pay royalties

The Endpoints 2024 winners and losers list: Who was up and who was down in biopharma

WuXi AppTec will sell cell and gene therapy business to private equity firm

CMS explains what went into its first round of drug price negotiations