Merck & Co. drug for treating NSCLC awarded FDA priority voucher

FDA-mandated report finds “insufficient data” to determine safety of PFAS in cosmetics

FDA has released a congressionally mandated report evaluating the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products.

January 09, 2026

Vol.52 No.1

By Claire Marie Porter

Drugs & Targets

FDA approves Rybrevant Faspro for EGFR-mutated NSCLC

FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously administered therapy for patients with epidermal growth factor receptor-mutated non-small cell lung cancer.

January 09, 2026

Vol.52 No.1

Drugs & Targets

FDA grants Enhertu Breakthrough Therapy designation as post-neoadjuvant therapy for HER2+ early breast cancer

FDA granted breakthrough therapy designation to Enhertu (trastuzumab deruxtecan) for adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.

January 09, 2026

Vol.52 No.1

Podcast

Otis Brawley looks back on a year of great science and greater challenges

In a year that brought us new KRAS-inhibiting drugs, deepened our understanding of HER2 in breast cancer, and highlighted new potential for mRNA vaccines, the cancer field was also rocked by uncertainty of the future of research funding, equity in cancer delivery, and the integrity of review at FDA.

December 31, 2025

Cancer Policy

Angelo de Claro named acting director of FDA Oncology Center of Excellence

Angelo de Claro was named acting director of the FDA Oncology Center of Excellence, following Richard Pazdur’s departure from that position—and the agency (The Cancer Letter, Dec. 5, 2025).

FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

FDA has approved rucaparib (Rubraca) for adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy.

December 19, 2025

Vol.51 No.46

Merck & Co. drug for treating NSCLC awarded FDA priority voucher

YOU MAY BE INTERESTED IN

FDA-mandated report finds “insufficient data” to determine safety of PFAS in cosmetics

FDA approves Rybrevant Faspro for EGFR-mutated NSCLC

FDA grants Enhertu Breakthrough Therapy designation as post-neoadjuvant therapy for HER2+ early breast cancer

Otis Brawley looks back on a year of great science and greater challenges

Angelo de Claro named acting director of FDA Oncology Center of Excellence

FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

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