Replimune Takes Third Swing at Cancer Drug Approval Following ‘Productive’ FDA Talks

Replimune got another attempt at lead drug after White House intervention: WSJ

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance following the resignation of former commissioner Marty Makary.

Replimune to resubmit twice-rejected drug for approval after FDA shakeup

Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and approvals.

Replimune plans third attempt at RP1 approval in coming days

Replimune gets third chance at US approval for skin cancer drug

Replimune to resubmit melanoma drug after FDA's Makary leaves

Thomas Fuller | Lightrocket | Getty Images Replimune plans to resubmit its melanoma drug to the Food and Drug Administration for review after a leadership exodus at the agency, the company said Friday. The FDA twice rejected Replimune’s melanoma treatment under the previous FDA leadership, including former Commissioner Marty Makary, who stepped down earlier this month. Replimune had accused the FDA of wrongfully blocking what some doctors see a…