Updated: Two years on from confirmatory trial halt, FDA submits more questions to Oncopeptides over Pepaxto withdrawal

Zachary Brennan

Senior Editor

Following up on last week’s meeting on FDA’s long-awaited proposal to withdraw the accelerated approval for Oncopeptides’ blood cancer drug Pepaxto (melphalan flufenamide), the FDA …

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

Updated: Two years on from confirmatory trial halt, FDA submits more questions to Oncopeptides over Pepaxto withdrawal

Zachary Brennan

Senior Editor

Sign up to read this article for free.

CagriSema’s weight loss data disappointed. What does Novo do next?

Three drugmakers sue US over 340B discounts to STD clinics they allege don’t qualify

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

FDA approves Lilly's Zepbound for sleep apnea, likely cracking open Medicare market

Deerfield wins fight to acquire Singular Genomics, beating out Tang Capital’s Concentra

Vertex gets 'vanza triple' approval and Trikafta expansion — with boxed warnings

Up­dat­ed: Two years on from con­fir­ma­to­ry tri­al halt, FDA sub­mits more ques­tions to On­copep­tides over Pepax­to with­draw­al

Zachary Brennan

Senior Editor

Sign up to read this article for free.

more like this

Ca­griSe­ma’s weight loss da­ta dis­ap­point­ed. What does No­vo do next?

Three drug­mak­ers sue US over 340B dis­counts to STD clin­ics they al­lege don’t qual­i­fy

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

FDA ap­proves Lil­ly's Zep­bound for sleep ap­nea, like­ly crack­ing open Medicare mar­ket

Deer­field wins fight to ac­quire Sin­gu­lar Ge­nomics, beat­ing out Tang Cap­i­tal’s Con­cen­tra

Ver­tex gets 'van­za triple' ap­proval and Trikaf­ta ex­pan­sion — with boxed warn­ings

Updated: Two years on from confirmatory trial halt, FDA submits more questions to Oncopeptides over Pepaxto withdrawal

CagriSema’s weight loss data disappointed. What does Novo do next?

Three drugmakers sue US over 340B discounts to STD clinics they allege don’t qualify

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

FDA approves Lilly's Zepbound for sleep apnea, likely cracking open Medicare market

Deerfield wins fight to acquire Singular Genomics, beating out Tang Capital’s Concentra

Vertex gets 'vanza triple' approval and Trikafta expansion — with boxed warnings