FDA final guidance on psychedelics opens the door to psycho-oncology research Guidance permits treatment without psychotherapy, alarming scientists, advocates

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

Clinical Guest Editorial

Like it or not, AI psycho-oncology care is already happening. Urgently needed: An ethical framework
Developers and mental health providers must share the same goal: Safe, equitable, trustworthy, and patient-centered care

In 2026, more than 900 million people are estimated to be regularly using generative artificial intelligence—computer systems capable of creating human-like text, images, audio, video, and other original content. AI is becoming integrated into nearly every aspect of daily life. Health care is no exception.

August 14, 2026

Vol.52 No.32

By Viktor Clark, Sean M. Dozier, AnnaLynn M. Williams, Cynthia M. Rand and Lee A. Kehoe

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

FDA final guidance on psychedelics opens the door to psycho-oncology research

Guidance permits treatment without psychotherapy, alarming scientists, advocates

YOU MAY BE INTERESTED IN

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

Like it or not, AI psycho-oncology care is already happening. Urgently needed: An ethical framework
Developers and mental health providers must share the same goal: Safe, equitable, trustworthy, and patient-centered care

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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FDA final guidance on psychedelics opens the door to psycho-oncology research

Guidance permits treatment without psychotherapy, alarming scientists, advocates

YOU MAY BE INTERESTED IN

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

Like it or not, AI psycho-oncology care is already happening. Urgently needed: An ethical frameworkDevelopers and mental health providers must share the same goal: Safe, equitable, trustworthy, and patient-centered care

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

Like it or not, AI psycho-oncology care is already happening. Urgently needed: An ethical framework
Developers and mental health providers must share the same goal: Safe, equitable, trustworthy, and patient-centered care