Browsing: FDA

FDA Voucher Program Oncology: Accelerated Approvals in Oncology On June 17, 2025, the FDA launched the Commissioner’s National Priority Voucher…

On June 3, 2025, the U.S. Food and Drug Administration (FDA) approved Darolutamide for de novo metastatic castration-sensitive prostate cancer…

FDA approves Penpulimab-kcqx / Anike The FDA approved Anike (Penpulimab-kcqx) on April 23, 2025, for non-keratinizing nasopharyngeal carcinoma (NPC, WHO…

A Novel Tyrosine Kinase Inhibitor Poised to Transform Advanced Lung Cancer Care Boehringer Ingelheim | Ridgefield, Conn., and Ingelheim, Germany…

On January 16, 2025, a significant advancement in cancer treatment was announced. The FDA approved a new therapeutic option for…

Overview The U.S. Food and Drug Administration (FDA) has granted approval for the use of inotuzumab ozogamicin (Besponsa, Pfizer) in…

On March 7, 2024, the Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib, marketed as Brukinsa by BeiGene…

The FDA granted Priority Review of the supplemental Biologics License Application (sBLA) for epcoritamab-bysp. This subcutaneously administered T-cell engaging bispecific…

Teclistamab FDA approval biweekly dosing in Relapsed or Refractory Multiple Myeloma (3 KOL Video Interviews Below) On February 20th, 2024…

In the interview, Susan Pandya, MD, Vice President of Clinical Development at Servier Pharmaceuticals, discusses the pivotal FDA acceptance and…

Marwan Fakih, MD – City of Hope – FDA Approval of LONSURF in combination with Bevacizumab The FDA approval of…

UCSF With FDA In Robotic Colorectal Surgery Trial: da Vinci SP [2022]   The da Vinci SP Surgical Systems So…

In this episode of The Onco’Zine Brief, Peter Hofland talks with Thorsten Sperber, Global Head Medical Affairs at Immunomedics. Hofland…