FDA approves Zynyz as first-line treatment for advanced anal cancer

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.

June 06, 2025

Drugs & Targets

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.

June 06, 2025

Drugs & Targets

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.

June 06, 2025

Drugs & Targets

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

FDA accepted a new drug application and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor, for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.

May 30, 2025

Vol.51 No.21

Drugs & Targets

Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer

Alligator Bioscience on May 26 announced that the European Commission granted orphan drug designation to HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.

May 30, 2025

Vol.51 No.21

Podcast

In The Headlines: Back to “business as usual” at FDA?

The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.

May 28, 2025

Vol.51 No.20

FDA approves Zynyz as first-line treatment for advanced anal cancer

YOU MAY BE INTERESTED IN

FDA approves Nubeqa for metastatic castration-sensitive prostate cancer

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

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

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer

In The Headlines: Back to “business as usual” at FDA?

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