Moderna’s mRNA cancer vaccine improves survival in phase IIb melanoma study—first observation of efficacy in an RCT

From “default dead” to living the future of cancer care
As founding CEO of GitLab, I went “founder mode” on my osteosarcoma

In November 2022, I was 43 years old, healthy, active, and the founding CEO of the publicly traded tech company GitLab.

August 14, 2026

Trump’s vaccine executive order draws criticism from medical community, may put cancer populations at risk

President Trump earlier this week issued an executive order that would drastically change the childhood immunization schedule—limiting recommendations, spacing out shots, and splitting the combined measles, mumps, and rubella vaccine into single-disease injections.

August 14, 2026

Vol.52 No.32

By Claire Marie Porter

Drugs & Targets

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

Moderna’s mRNA cancer vaccine improves survival in phase IIb melanoma study—first observation of efficacy in an RCT

YOU MAY BE INTERESTED IN

From “default dead” to living the future of cancer care
As founding CEO of GitLab, I went “founder mode” on my osteosarcoma

Trump’s vaccine executive order draws criticism from medical community, may put cancer populations at risk

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

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Moderna’s mRNA cancer vaccine improves survival in phase IIb melanoma study—first observation of efficacy in an RCT

YOU MAY BE INTERESTED IN

From “default dead” to living the future of cancer careAs founding CEO of GitLab, I went “founder mode” on my osteosarcoma

Trump’s vaccine executive order draws criticism from medical community, may put cancer populations at risk

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

Never miss an issue!

Login

From “default dead” to living the future of cancer care
As founding CEO of GitLab, I went “founder mode” on my osteosarcoma

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