China’s NMPA approves lisaftoclax for CLL or SLL

FDA approves Blenrep combination for relapsed/refractory multiple myeloma after two or more lines of therapy

FDA approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

October 24, 2025

Vol.51 No.39

Drugs & Targets

CHMP adopts positive opinion for Libtayo as adjuvant treatment for high-risk CSCC

Regeneron Pharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells.

October 24, 2025

Vol.51 No.39

Clinical Roundup

Study assesses cancers in children exposed to medical imaging

Ten percent of pediatric blood and bone marrow cancers may have stemmed from radiation exposure, according to a study led by UC San Francisco and UC Davis.

September 26, 2025

Vol.51 No.35

Drugs & Targets

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

FDA approved gemcitabine intravesical system (Inlexzo) for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

September 19, 2025

Vol.51 No.34

Drugs & Targets

FDA approves Bosaya and Aukelso, denosumab biosimilars, for osteoporosis

FDA approved Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) injections, biosimilars of Prolia and Xgeva respectively, for the treatment of osteoporosis. In addition, FDA granted provisional interchangeability designation for both Bosaya and Aukelso.

September 19, 2025

Vol.51 No.34

Cancer Policy

FDA will speed up public release of Complete Response Letters

FDA is shortening its timeline for publicizing Complete Response Letters, pledging to make them available to the public “promptly” after sponsors receive notice.

September 05, 2025

Vol.51 No.32

By Sara Willa Ernst