FDA issues revised draft guidance on charging for investigational drugs under an IND application

Raja Flores says oncology is loose with staging jargon, and now “it’s confusing my patients.”

In last week’s issue of The Cancer Letter, Raja Flores wrote a guest editorial explaining how he, with his expertise in thoracic surgery, took issue with a nuance in a recent Keytruda commercial.

August 19, 2026

Drugs & Targets

FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma

FDA granted accelerated approval to iberdomide (Zenbexus) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

August 14, 2026

Vol.52 No.32

Drugs & Targets

FDA advisory committee to vote on GRAIL’s multi-cancer detection test, Galleri

FDA announced a forthcoming hybrid meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee on Sept. 23 to discuss, make recommendations, and vote on information regarding the premarket approval application for the Galleri test sponsored by GRAIL, Inc.

August 14, 2026

Vol.52 No.32

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

FDA issues revised draft guidance on charging for investigational drugs under an IND application

YOU MAY BE INTERESTED IN

Raja Flores says oncology is loose with staging jargon, and now “it’s confusing my patients.”

FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma

FDA advisory committee to vote on GRAIL’s multi-cancer detection test, Galleri

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

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FDA issues revised draft guidance on charging for investigational drugs under an IND application

YOU MAY BE INTERESTED IN

Raja Flores says oncology is loose with staging jargon, and now “it’s confusing my patients.”

FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma

FDA advisory committee to vote on GRAIL’s multi-cancer detection test, Galleri

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

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