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 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.
FDA and OS Therapies held a Type C meeting regarding the phase IIb human clinical trial of OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma.
FDA has awarded a National Priority Voucher to teclistamab (Tecvayli) in combination with daratumumab (Darzalex) for relapsed/refractory multiple myeloma. This brings the total number of products receiving an award under the Commissioner’s National Priority Voucher pilot program to 16.
Last month, FDA withdrew a proposed rule for standardized asbestos testing in talc-based cosmetics. The proposed rule, introduced in Nov. 2024 and withdrawn Nov. 2025, was mandated by the Modernization of Cosmetics Regulation Act of 2022 or MoCRA.
FDA has withdrawn a proposed rule that called for standardized testing for detecting and identifying asbestos in talc-containing cosmetic products.
Scott Gottlieb, a former FDA commissioner, said a recent decision by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices’ to change its recommendation for when children should receive the hepatitis B vaccine is another sign of the ACIP’s diminished credibility as a scientific authority.
After three weeks of brutal combat, Richard Pazdur decided that he has had enough.
Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, has instructed his staff to check with him before continuing to work on ongoing submissions to journals or beginning new contract-funded projects to “ensure that we are not engaging in sunk cost fallacy, not publishing obviously erroneous work, and not being distracted from our core mission.”
FDA issued a draft guidance on Dec. 2, outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or reduced.
