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Drug Launches & Approvals

Johnson & Johnson

FDA Approves Johnson & Johnson’s DARZALEX FASPRO (Daratumumab and Hyaluronidase-fihj) for High-Risk Smoldering Multiple Myeloma: Advancing Early Multiple Myeloma Intervention

The multiple myeloma therapeutic landscape has undergone a significant transformation with the FDA’s approval of Johnson & Johnson (NYSE:JNJ)’s DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). This regulatory milestone, announced on November
28 November 2025
FDA Approval

FDA Approves Merck’s KEYTRUDA and KEYTRUDA QLEX in Combination with Astellas Pharma’s PADCEV as Perioperative Treatment for Muscle-Invasive Bladder Cancer

The muscle-invasive bladder cancer (MIBC) treatment landscape has undergone a transformation with the FDA’s approval of KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Astellas Pharma’ PADCEV (enfortumab vedotin-ejfv), as perioperative treatment for adult patients with MIBC
28 November 2025
AstraZeneca

FDA Approves AstraZeneca’s Durvalumab (IMFINZI): A Paradigm Shift in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma Treatment

The therapeutic landscape for resectable gastric and gastroesophageal junction adenocarcinoma (GC/GEJC) has undergone a significant transformation with the FDA’s approval of durvalumab (AstraZeneca) on November 25, 2025, for use in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and
27 November 2025

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