Sanofi Secures EU Conditional Approval for Rezurock in Chronic Graft-Versus-Host Disease
Sanofi (NASDAQ: SNY) announced that the European Commission (EC) has granted conditional marketing authorization for...
Product approvals
Biogen Secures FDA Approval for High-Dose Spinraza Regimen in Spinal Muscular Atrophy
Biogen Inc. (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved...
Amoy Diagnostics and HutchMed Secure World’s First NMPA Approval for MET Amplification Companion Diagnostic
Amoy Diagnostics Co., Ltd. (SHE: 300685) and HutchMed (China) Ltd. (NASDAQ: HCM, HKG: 0013) have...
Boston Scientific Secures FDA 510(k) Clearance for Asurys Fluid Management System in Kidney Stone Procedures
Boston Scientific (NYSE: BSX) has announced FDA 510(k) clearance for its Asurys Fluid Management System,...
Teva Secures FDA Approval for Prolia Biosimilar Ponlimsi, Advances Xolair Copycat Through Regulatory Channels
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has announced FDA marketing approval for Ponlimsi, its biosimilar...
Roche Launches cobas MPX-E Test in CE Markets, Consolidating Four-Virus Detection for Enhanced Blood Safety
Roche AG (SWX: ROG, OTCMKTS: RHHBY) has announced the commercial launch of its cobas MPX-E...
NMPA Approves GSK’s Exdensur as First Ultra-Long-Acting Biologic for Severe Eosinophilic Asthma
China’s National Medical Products Administration (NMPA) has approved GlaxoSmithKline plc (GSK, NYSE: GSK)’s Exdensur (depemokimab)...
Hansoh Pharma’s Uplizna Gains Third NMPA Approval in China for Generalized Myasthenia Gravis, Expanding CD19 Antibody Franchise
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China’s National Medical Products Administration (NMPA)...
Huadong Medicine’s YY001 Becomes World’s First Recombinant Botulinum Toxin Approved in China for Glabellar Lines
Huadong Medicine Co., Ltd. (SHE: 000963) announced that China’s National Medical Products Administration (NMPA) has...
AstraZeneca’s Tezspire Gains Dual NMPA Approvals in China for Severe Asthma and Nasal Polyps Based on Pivotal Phase III Data
AstraZeneca plc (NYSE: AZN) announced that China’s National Medical Products Administration (NMPA) has approved Tezspire®...
Medtronic’s Stealth AXiS Surgical System Gains FDA Approval for Cranial and ENT Procedures, Expanding Beyond Spine
Medtronic plc (NYSE: MDT) announced it has received U.S. Food and Drug Administration (FDA) marketing...
J&J’s Darzalex SC Becomes First Oncology Injectable in Europe Approved for Patient Self-Administration
Johnson & Johnson (J&J, NYSE: JNJ) announced that the Committee for Medicinal Products for Human...
UCB’s Bimzelx Wins NMPA Approval for Two New Indications – IL-17A/F Dual-Target Antibody Expands into Psoriasis and Hidradenitis Suppurativa
UCB (EBR: UCB) announced National Medical Products Administration (NMPA) approval for Bimzelx (bimekizumab) in two...
Enhertu Wins China Approval for HER2+ Early Breast Cancer – ADC Sequential Therapy Shows 67% pCR Rate in Phase III DESTINY-Breast11
Enhertu (trastuzumab deruxtecan), the HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (NYSE: AZN) and Daiichi...
Lee’s Pharma Wins NMPA Approval for Intrarosa – Estrogen-Free DHEA Pessary Targets Postmenopausal Vulvovaginal Atrophy
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) announced National Medical Products Administration (NMPA) marketing approval for...
Bayer/Regeneron’s Eylea HD Wins Japan Approval for RVO – Third Indication Nod with Extended Dosing Demonstrates 3 Fewer Injections
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Eylea HD (aflibercept) injection 8...
Sanofi’s Dupixent Wins Japan Approval for Bullous Pemphigoid – Seventh Indication Expands IL‑4/IL‑13 Franchise
Sanofi S.A. (NASDAQ: SNY) announced that Dupixent (dupilumab) has received marketing approval from Japan’s Ministry...
RemeGen Secures Fourth NMPA Approval for Disitamab Vedotin – HER2‑Low Breast Cancer with Liver Metastases Indication Expands ADC Franchise
RemeGen Co., Ltd. (SHA: 688331, HKG: 9995) announced NMPA approval for a new indication of...
Grand Pharma Wins NMPA Approval for GPN01768 – First Targeted Therapy for Demodex Blepharitis in China
Grand Pharmaceutical Group (HKG: 0512) announced that its licensed‑in global innovative ophthalmic drug GPN01768 [TP‑03,...
GSK Wins FDA Approval for Lynavoy – First US Treatment for PBC Cholestatic Pruritus as Alfasigma Acquisition Nears Close
GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the US Food and Drug Administration (FDA) has...