Introduction: A New Tool for Breast Cancer Treatment On September 25, 2025, the FDA approved Inluriyo (imlunestrant), an oral selective…
Browsing: FDA Approval
The FDA approved INLEXZO™ / gemcitabine intravesical on September 9, 2025, to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with…
Introduction to Datopotamab Deruxtecan EGFR-Mutated NSCLC On June 23, 2025, the FDA approved Datopotamab Deruxtecan EGFR-Mutated NSCLC treatment, known as…
On June 11, 2025, the U.S. Food and Drug Administration (FDA) approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a new kinase…
On June 3, 2025, the U.S. Food and Drug Administration (FDA) approved Darolutamide for de novo metastatic castration-sensitive prostate cancer…
Published: May 30, 2025 Pfizer shared results from the BRAFTOVI BREAKWATER trial at ASCO 2025. The trial tested BRAFTOVI® (encorafenib) with cetuximab…
FDA approves Penpulimab-kcqx / Anike The FDA approved Anike (Penpulimab-kcqx) on April 23, 2025, for non-keratinizing nasopharyngeal carcinoma (NPC, WHO…
Date: April 8, 2025 On April 8, 2025, the FDA granted regular approval to nivolumab (Opdivo) combined with ipilimumab (Yervoy)…
Date: March 19, 2025 On March 19, 2025, the U.S. Food and Drug Administration (FDA) granted traditional approval to pembrolizumab…
March 4, 2025 New Treatment Option for ESCC Patients The U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr)…
Overview of the ASCENT Trial and Trodelvy The ASCENT Trial (NCT02574455) is a Phase III study that compares Trodelvy (Sacituzumab…