Roy Herbst elected to Friends board of directors

Nuvalent announces positive topline pivotal data from ALKOVE-1 trial of neladalkib for TKI pre-treated patients with advanced ALK-positive NSCLC

Nuvalent, a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, announced positive topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in tyrosine kinase inhibitor pre-treated patients with advanced ALK-positive non-small cell lung cancer from the global ALKOVE-1 phase I/II clinical trial.

November 21, 2025

Vol.51 No.43

Drugs & Targets

FDA approves Hyrnuo for HER2-mutated NSCLC

FDA has approved Hyrnuo (sevabertinib), an oral, reversible, tyrosine kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

November 21, 2025

Vol.51 No.43

Drugs & Targets

Microsoft and Qure.ai collaborate to accelerate AI lung cancer detection

Microsoft and Qure.ai announced a collaboration that will streamline deployment of Qure.ai solutions to hospitals and health systems across the U.S.

November 21, 2025

Vol.51 No.43

Conversation with The Cancer Letter Regulatory News

Richard Pazdur, a respected insider with a plan to reengineer FDA, steps in as CDER director

Richard Pazdur, FDA’s top oncologist who last week received a battlefield promotion to the role of director of the FDA Center for Drug Evaluation and Research, is described as a stabilizing figure respected by major patient groups, oncology professional societies, and the industry.

Rick Pazdur’s CDER appointment comes at exactly the right moment for FDA

Rick Pazdur’s appointment as director of the FDA’s Center for Drug Evaluation and Research (CDER) comes at exactly the right moment, both for the agency and for the patients it serves.

November 14, 2025

Vol.51 No.42

By Ellen V. Sigal

City of Hope’s leadership in lung cancer: Precision, innovation, and a vision for cure

As we mark Lung Cancer Awareness Month, it is a time to acknowledge that screening and prevention are vital, and equally crucial is ensuring that patients have access to state-of-the-art care and research. Herein, I spotlight some of the transformative work underway at City of Hope.

November 07, 2025

Vol.51 No.41

By Ravi Salgia