House Energy & Commerce hearing focuses on America’s leadership in biomedical research, examines FDA role

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

Guest Editorial

The defining question of the next decade is not how many drug candidates can be generated, but who decides which ones move forward, and why
Drug development must convene a forum for candid, cross-sector discussion

At the 2026 Annual Meeting of the American Society of Clinical Oncology in Chicago, results from the phase III HARMONi-6 trial were presented at the plenary session and published simultaneously in The Lancet. The HARMONi-6 trial tested a novel bispecific antibody that engages PD-1 and VEGF (ivonescimab), given with platinum-doublet chemotherapy to patients with previously untreated advanced squamous non-small cell lung cancer.

August 14, 2026

Vol.52 No.32

By Richard L. Schilsky, H. Kim Lyerly, Thomas R. Fleming and Renzo Canetta

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

House Energy & Commerce hearing focuses on America’s leadership in biomedical research, examines FDA role

YOU MAY BE INTERESTED IN

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

The defining question of the next decade is not how many drug candidates can be generated, but who decides which ones move forward, and why
Drug development must convene a forum for candid, cross-sector discussion

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

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House Energy & Commerce hearing focuses on America’s leadership in biomedical research, examines FDA role

YOU MAY BE INTERESTED IN

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

The defining question of the next decade is not how many drug candidates can be generated, but who decides which ones move forward, and whyDrug development must convene a forum for candid, cross-sector discussion

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

Never miss an issue!

Login

The defining question of the next decade is not how many drug candidates can be generated, but who decides which ones move forward, and why
Drug development must convene a forum for candid, cross-sector discussion