Drug Launches & Approvals Archives - Pharma Globenewswire

FDA Approves Agios’ AQVESME (mitapivat) as First Oral Therapy for Thalassemia: A Watershed Moment for Anemia Management

The Food and Drug Administration (FDA) has granted approval to AQVESME (mitapivat), marking a historic milestone in the thalassemia treatment. As the first oral therapy indicated for adults with both non-transfusion-dependent (NTD) and transfusion-dependent (TD) alpha- or beta-thalassemia, this approval represents a

21 January 2026

Drug Launches & Approvals

FDA Approves ZYCUBO (Copper Histidinate): First-Ever Treatment for Menkes Disease

Sentynl Therapeutics, a US-based biopharmaceutical subsidiary of Zydus Lifesciences Limited, has achieved a landmark regulatory milestone with FDA approval of ZYCUBO (copper histidinate) injection for the treatment of pediatric patients with Menkes disease. This marks the first and only FDA-approved therapy for

15 January 2026

Drug Launches & Approvals

Strong Interim Results from Protara’s TARA‑002 in Pediatric Lymphatic Malformations

Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer and rare diseases, has announced encouraging interim findings from its ongoing Phase 2 open-label STARBORN-1 trial. The study evaluates the intracystic administration of TARA-002, the company’s

1 December 2025

Drug Launches & Approvals

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

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

1 December 2025

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

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

Drug Launches & Approvals

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

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

28 November 2025

Drug Launches & Approvals

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

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.

28 November 2025

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

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

Drug Launches & Approvals

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

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

28 November 2025

Drug Launches & Approvals

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

Drug Launches & Approvals

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

FDA Approves Agios’ AQVESME (mitapivat) as First Oral Therapy for Thalassemia: A Watershed Moment for Anemia Management

FDA Approves ZYCUBO (Copper Histidinate): First-Ever Treatment for Menkes Disease

Strong Interim Results from Protara’s TARA‑002 in Pediatric Lymphatic Malformations

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

Recent Posts

Recent Comments

Hi There!

Banner

Latest Interviews

Newsletter

Authors

pharmaglobenews

Michael Ashford

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

Suggestions

Drug Launches & Approvals

Recent Posts

Recent Comments

Hi There!

Banner

Latest Interviews

Newsletter

Authors