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FDA Drug Approval Controversy: Melanoma Drug Rejection Sparks Debate | Replimune RP1 BLA Resubmission Accepted by FDA; PDUFA Date Set for April 10, 2026 | FDA Rejects Replimune Skin Cancer Therapy RP1: What This Means for Patients | FDA Drug Approval Controversy: Melanoma Drug Rejection Sparks Debate | Replimune RP1 BLA Resubmission Accepted by FDA; PDUFA Date Set for April 10, 2026 | FDA Rejects Replimune Skin Cancer Therapy RP1: What This Means for Patients

Health / Science

FDA Drug Approval Controversy: Melanoma Drug Rejection Sparks Debate

The Food and Drug Administration (FDA) is facing scrutiny over its recent drug approval decisions, particularly the rejection of RP1, a melanoma drug candidate from Replimune. This decision has sparked debate among researchers, clinicians,...

Watch CNBC's full interview with FDA Commissioner Marty Makary
FDA Drug Approval Controversy: Melanoma Drug Rejection Sparks Debate Image via CNBC
TOPIC replimune

News / FDA Approvals

Replimune RP1 BLA Resubmission Accepted by FDA; PDUFA Date Set for April 10, 2026

Replimune (NASDAQ: REPL) announced that the FDA has accepted the Biologics License Application (BLA) resubmission for RP1, in combination with nivolumab, for the treatment of advanced melanoma. The FDA has set a PDUFA target action date of...

PDUFA Apr 10, 2026: Replimune's BLA Resubmission for RP1 Accepted by FDA for Advanced Melanoma

News / FDA

FDA Rejects Replimune Skin Cancer Therapy RP1: What This Means for Patients

The FDA has rejected Replimune Group's RP1, a viral-based therapy intended for advanced skin cancer, due to inadequate trial data. This decision highlights the agency's increasingly stringent approach to new drug approvals and raises concer...

Replimune skin cancer therapy rejected by FDA