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 …

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

Lei Lei Wu

News Reporter

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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.

Trump names Johns Hop­kins re­searcher Mar­ty Makary to lead the FDA; al­so names CDC, Sur­geon Gen­er­al picks

FDA ap­proves Bridge­Bio's heart dis­ease drug, set­ting up com­pe­ti­tion with Pfiz­er, Al­ny­lam

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

Trump names Johns Hopkins researcher Marty Makary to lead the FDA; also names CDC, Surgeon General picks

FDA approves BridgeBio's heart disease drug, setting up competition with Pfizer, Alnylam

Drug or biologic? An Eli Lilly lawsuit could impact weight loss drug compounders

Lilly's board undergoes more changes; Merck strategy chief joins Roger Perlmutter at Eikon

Surrounded by AI bio giants, tiny startup Nabla Bio makes de novo antibodies look more like drugs

Are programs with compounded GLP-1s safe for your population?