Pharma Globenewswire

POHERDY Gains FDA Approval: A New Biosimilar for HER2‑Positive Breast Cancer

1 December 2025

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) have announced that the U.S. FDA has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab‑dpzb) 420 mg/14 mL injection for intravenous administration. This interchangeable biosimilar to PERJETA (pertuzumab) is approved for all

Drug Launches & Approvals

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

28 November 2025

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

Drug Launches & Approvals

FDA Approves AstraZeneca’s KOSELUGO (Selumetinib) for Adults with Neurofibromatosis Type 1 with Inoperable Plexiform Neurofibromas

28 November 2025

The pharmaceutical landscape for neurofibromatosis type 1 (NF1) treatment has reached a significant turning point with the FDA’s approval of KOSELUGO (selumetinib, AstraZeneca Pharmaceuticals LP) on November 19, 2025, for adults with NF1 who have symptomatic, inoperable plexiform neurofibromas (PN). This regulatory

Drug Launches & Approvals

FDA Approves Amgen’s IMDELLTRA (Tarlatamab-dlle): A Breakthrough in Extensive Stage Small Cell Lung Cancer Treatment

28 November 2025

The pharmaceutical landscape for extensive stage small cell lung cancer (ES-SCLC) treatment has reached a significant inflection point with the FDA’s traditional approval of IMDELLTRA (tarlatamab-dlle) on November 19, 2025, for adults with ES-SCLC with disease progression on or after platinum-based chemotherapy.

Drug Launches & Approvals

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

28 November 2025

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

Drug Launches & Approvals

Novartis Receives FDA Approval for ITVISMA Gene Replacement Therapy in Spinal Muscular Atrophy

28 November 2025

Novartis received the FDA approval for ITVISMA (onasemnogene abeparvovec-brve) on 24th November 2025, marking a significant milestone for patients living with spinal muscular atrophy (SMA) and the broader neurological disease. This regulatory decision establishes ITVISMA as the first and only gene replacement

Drug Launches & Approvals

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

27 November 2025

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

Drug Launches & Approvals

FDA Approves Otsuka’s VOYXACT (Sibeprenlimab-szsi): A Breakthrough in Primary Immunoglobulin A Nephropathy Treatment

27 November 2025

The pharmaceutical landscape for immunoglobulin A nephropathy (IgAN) treatment has reached a significant inflection point with the FDA’s accelerated approval of VOYXACT (sibeprenlimab-szsi) on November 25, 2025, for the reduction of proteinuria in adults with primary IgAN at risk for disease progression.

Clinical Trials

Global AI in Medical Diagnostics Market Set for Exceptional Growth at a CAGR of ~22% by 2032 | DelveInsight

20 November 2025

The global artificial intelligence (AI) in medical diagnostics market is expanding at a rapid pace, driven by the rising incidence of chronic, genetic, and infectious diseases. AI-powered diagnostic solutions enable earlier detection, more accurate diagnoses, and personalized treatment planning by analyzing complex

Latest

POHERDY Gains FDA Approval: A New Biosimilar for HER2‑Positive Breast Cancer

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

FDA Approves AstraZeneca’s KOSELUGO (Selumetinib) for Adults with Neurofibromatosis Type 1 with Inoperable Plexiform Neurofibromas

FDA Approves Amgen’s IMDELLTRA (Tarlatamab-dlle): A Breakthrough in Extensive Stage Small Cell Lung Cancer Treatment

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

Novartis Receives FDA Approval for ITVISMA Gene Replacement Therapy in Spinal Muscular Atrophy

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

FDA Approves Otsuka’s VOYXACT (Sibeprenlimab-szsi): A Breakthrough in Primary Immunoglobulin A Nephropathy Treatment

Global AI in Medical Diagnostics Market Set for Exceptional Growth at a CAGR of ~22% by 2032 | DelveInsight

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