Tafinlar-Mekinist Combination Shows Significant Benefit in BRAF V600E/K Population

FDA approves companion diagnostic supporting patients with advanced melanoma

FDA approved Labcorp’s PGDx elio tissue complete CDx as a companion diagnostic to help identify patients with advanced melanoma with certain BRAF variants who may benefit from treatment with FDA-approved targeted therapies.

August 14, 2026

Vol.52 No.32

Podcast

What happened at FDA? Replimune approval raises questions

Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.

August 12, 2026

Regulatory News

FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committee
Amid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial

FDA has granted an accelerated approval to RP1 (vusolimogene oderparepvec) following the agency’s Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.

August 07, 2026

Vol.52 No.31

By Jacquelyn Cobb and Paul Goldberg

Drugs & Targets

After two CRLs, FDA advisory committee votes in favor of Replimune’s melanoma drug

FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 10:3 in favor of Replimune’s Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

July 31, 2026

Vol.52 No.30

Drugs & Targets

FDA expands sunscreen options for the first time in 20 years

FDA added bemotrizinol to the list of permitted sunscreen active ingredients, marking the first new active ingredient added to the over-the-counter sunscreen monograph since the late 1990s.

June 12, 2026

Vol.52 No.23

Clinical Roundup

Dermatologists and oncologists call for overhaul of widely used cancer side-effect grading system

Physicians at the Icahn School of Medicine at Mount Sinai are calling for updates to a widely used system that grades side effects from cancer treatments, warning that current criteria may misclassify the severity of skin-related toxicities and limit consistency across clinical trials.

May 29, 2026

Vol.52 No.21

Tafinlar-Mekinist Combination Shows Significant Benefit in BRAF V600E/K Population

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FDA approves companion diagnostic supporting patients with advanced melanoma

What happened at FDA? Replimune approval raises questions

FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committee
Amid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial

After two CRLs, FDA advisory committee votes in favor of Replimune’s melanoma drug

FDA expands sunscreen options for the first time in 20 years

Dermatologists and oncologists call for overhaul of widely used cancer side-effect grading system

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Tafinlar-Mekinist Combination Shows Significant Benefit in BRAF V600E/K Population

YOU MAY BE INTERESTED IN

FDA approves companion diagnostic supporting patients with advanced melanoma

What happened at FDA? Replimune approval raises questions

FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committeeAmid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial

After two CRLs, FDA advisory committee votes in favor of Replimune’s melanoma drug

FDA expands sunscreen options for the first time in 20 years

Dermatologists and oncologists call for overhaul of widely used cancer side-effect grading system

Never miss an issue!

Login

FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committee
Amid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial