IASO Biotherapeutics’ Fucaso Becomes First BCMA CAR-T Therapy Approved in Singapore for Relapsed/Refractory Multiple Myeloma
IASO Biotherapeutics announced that Singapore’s Health Sciences Authority (HSA) has approved the New Drug Application...
Drug
Sanofi’s Sarclisa Subcutaneous Formulation Approved in Japan for Multiple Myeloma Across Treatment Settings
Sanofi (NASDAQ: SNY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved...
Roche’s Lunsumio-Polatuzumab Combination Accepted for FDA Review in Relapsed/Refractory Large B-Cell Lymphoma
Roche Holding AG (SWX: ROP; OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration...
Sunshine Lake Pharma Advances Novel LY6G6D/4-1BB Bispecific Antibody HEC-921 Toward Phase I Clinical Trials in China
Sunshine Lake Pharma Co., Ltd. (HKG: 6887) announced that its investigational new drug application for...
Merck’s Capvaxive Pneumococcal Vaccine Expands to Pediatric Population with FDA Approval for Ages 2-17
Merck & Co., Inc. (MSD, NYSE: MRK), known as MSD outside the United States, announced...
CSPC Pharmaceutical’s Efmedaglutide Alfa GLP-1 Therapy Accepted for NMPA Review in Type 2 Diabetes Indication
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has...
CSPC Pharmaceutical’s Cosentyx Biosimilar Accepted for NMPA Review in China’s Competitive IL-17A Market
CSPC Pharmaceutical Group (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has accepted...
CSPC Pharmaceutical Secures FDA Clearance for SYHX2008 Octreotide Biosimilar Clinical Trials in US Market
CSPC Pharmaceutical Group (HKG: 1093) announced that the U.S. Food and Drug Administration (FDA) has...
Johnson & Johnson Secures Second NMPA Approval for Akeega in BRCA2-Mutated Metastatic Prostate Cancer Following AMPLITUDE Trial Success
Johnson & Johnson (J&J, NYSE: JNJ) announced that China’s National Medical Products Administration (NMPA) has...
Hotgen Biotech Secures NMPA Approval for SGT003 Bispecific Antibody Targeting Tumor Microenvironment
Hotgen Biotech Co., Ltd (SHA: 688068) announced that China’s National Medical Products Administration (NMPA) has...
GSK and Spero Therapeutics Secure FDA Approval for Utebzi, First Oral Carbapenem Antibiotic for Complicated UTIs
GlaxoSmithKline plc (GSK) (NYSE: GSK) and Spero Therapeutics (NASDAQ: SPRO) announced that the U.S. Food...
Shanghai Henlius Biotech Secures NMPA Approval for Phase I Trial of HLX3902 Trispecific Antibody in Advanced Solid Tumors
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
Hopstem Biotechnology Secures FDA Clearance for hNPC01 Neural Progenitor Cell Therapy in Hemorrhagic Stroke Motor Dysfunction
Hopstem Biotechnology Co., Ltd., a neural stem cell specialist founded by neuroscientists and stem-cell biologists...
Walvax Biotechnology’s 13-Valent Pneumococcal Vaccine Weuphoria Meets All Endpoints in Indonesian Phase III Trial
Walvax Biotechnology Co., Ltd (SHE: 300142) announced that its Phase III clinical study for Weuphoria,...
Insilico Medicine’s NLRP3 Inhibitor ISM8969 Achieves First-in-Human Milestone in Phase I Trial for CNS Disorders
Insilico Medicine (HKG: 3696) announced that ISM8969, jointly developed with Hygtia Therapeutics Co., Ltd., has...
Hengrui Pharmaceuticals Expands Dalpiciclib Label with NMPA Approval for Early Breast Cancer Adjuvant Therapy
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received additional indication...
Hengrui Pharmaceuticals Receives NMPA Clinical Approvals for Two Novel Anti-Tumor Candidates SHR-6914 and HRS-7525, Addressing Unmet Needs in Prostate Cancer and Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received separate clinical...
Zai Lab’s DLL3-Targeting ADC Zocilurtatug Pelitecan Receives EMA Orphan Drug Designation for Pulmonary Neuroendocrine Carcinomas
Zai Lab Limited (NASDAQ: ZLAB; HKG: 9688) announced that the European Medicines Agency (EMA) has...
Luye Pharma’s Dual-Target Candidate LY03015 Achieves Breakthrough Phase II Results in Tardive Dyskinesia with 76.5% Response Rate
Luye Pharma Group Limited (HKG: 2186) announced that its Category 1 candidate drug LY03015 has...
GSK’s Momelotinib Receives Orphan Drug Designation from FDA and EMA for VEXAS Syndrome, Addressing Critical Unmet Need in Rare Myeloid Disorder
GlaxoSmithKline plc (GSK) (NYSE: GSK) announced that momelotinib has received Orphan Drug Designation (ODD) from...