Enhertu receives FDA approval for breast cancer indication

FDA approves Nubeqa for metastatic castration-sensitive prostate cancer

FDA approved the oral androgen receptor inhibitor Nubeqa (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer, which is also known as metastatic hormone-sensitive prostate cancer.

Clairity becomes the first FDA-authorized AI platform for breast cancer prediction

Clairity Inc. received FDA De Novo authorization for CLAIRITY BREAST, a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram. With this authorization, Clairity is planning to launch among leading health systems through 2025—propelling a new era of precision medicine in breast cancer.

EC approves Adcetris for newly diagnosed Hodgkin lymphoma in combination with ECADD

The European Commission June 3 approved Adcetris (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone—a chemotherapy regimen—in adult patients with newly diagnosed stage 2b with risk factors, stage 3, and stage 4 Hodgkin lymphoma. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use on April 25.

China’s NMPA approves zanidatamab in China for previously treated, unresectable or metastatic HER2+ biliary tract cancer

The National Medical Products Administration in China approved zanidatamab for the treatment of patients with previously treated, unresectable or metastatic HER2-positive biliary tract cancer.

Meitheal Pharmaceuticals launches generic paclitaxel formulation in the U.S.

Meitheal Pharmaceuticals Inc. on May 29 announced it has launched, through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd., paclitaxel protein-bound particles for injectable suspension (albumin-bound), a generic form of Abraxane, in the U.S.