FDA approves label expansion for VENTANA PD-L1 assay to identify patients with locally advanced and metastatic NSCLC eligible for Libtayo

Optimizing dosing of expensive and toxic oncology drugs: Making America healthier

There is general agreement that the United States spends too much on health care, especially on pharmaceuticals. But what we spend on drugs is not simply a function of price. If eggs double in price, people can simply cut the number of eggs they eat in half. Simply stated, cost is the product of (price per unit times the number of units purchased).

FDA to issue “national priority vouchers” to companies supporting U.S. interests

A new FDA voucher program will aim to accelerate review time for applications that are deemed to be advancing U.S. “national priorities.”

June 20, 2025

Vol.51 No.24

By Claire Marie Porter

Cancer Policy

Vinay Prasad named chief medical and scientific officer at FDA

Vinay Prasad, a MAHA-aligned hematologist-oncologist with an avid cyber following, who was named director of the FDA Center for Biologics Evaluation and Research in early May (The Cancer Letter, May 9, 2025), has now been also appointed chief medical and science officer at FDA, according to an internal memo obtained by The Cancer Letter.

June 20, 2025

Vol.51 No.24

By Claire Marie Porter

Cancer Policy

FDA halts new clinical trials that export Americans’ cells to foreign labs in hostile countries

FDA has announced that the agency will begin immediately reviewing all new clinical trials that include shipping American citizens’ living cells to “China and other hostile countries for genetic engineering and subsequent infusion” back into American patients.

June 20, 2025

Vol.51 No.24

By Claire Marie Porter

Clinical Roundup

Talvey + Tecvayli show deep and durable responses in heavily pretreated MM patients with extramedullary disease

Johnson & Johnson announced on June 15 new results from the phase II RedirecTT-1 study evaluating the investigational combination of Talvey (talquetamab-tgvs), the first U.S. FDA-approved GPRC5D-directed bispecific antibody, and Tecvayli (teclistamab-cqyv), the first FDA-approved BCMA-directed bispecific antibody.

June 20, 2025

Vol.51 No.24

Drugs & Targets

FDA approves Zusduri for intravesical solution in recurrent LG-IR-NMIBC

FDA has approved Zusduri as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.

June 20, 2025

Vol.51 No.24

FDA approves label expansion for VENTANA PD-L1 assay to identify patients with locally advanced and metastatic NSCLC eligible for Libtayo

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Optimizing dosing of expensive and toxic oncology drugs: Making America healthier

FDA to issue “national priority vouchers” to companies supporting U.S. interests

Vinay Prasad named chief medical and scientific officer at FDA

FDA halts new clinical trials that export Americans’ cells to foreign labs in hostile countries

Talvey + Tecvayli show deep and durable responses in heavily pretreated MM patients with extramedullary disease

FDA approves Zusduri for intravesical solution in recurrent LG-IR-NMIBC

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