CARsgen Therapeutics Secures World’s First Solid Tumor CAR-T Approval with Kylimei for Gastric Cancer
CARsgen Therapeutics Holdings Limited (HKG: 2171) announced that its CAR-T therapy Kylimei (satricabtagene autoleucel injection)...
Drug
MacroGenics Secures $24.5M Milestone from Sanofi Following FDA Approval Expansion for Tzield in Type 1 Diabetes
MacroGenics, Inc. (NASDAQ: MGNX) announced it will receive a USD 24.5 million regulatory milestone payment...
Pfizer Reports Mixed Phase 3 Results for Sigvotatug Vedotin in Non-Small Cell Lung Cancer
Pfizer Inc. (NYSE: PFE) announced topline results from the Phase 3 SigVie-002 study (formerly Be6A...
Gan & Lee Pharmaceuticals Secures UAE Approval for Insulin Glargine Prefilled Pen, Expanding Global Diabetes Portfolio
Gan & Lee Pharmaceuticals (SHA: 603087) announced that the Ministry of Health and Prevention (MOHAP)...
Mabwell Bioscience Presents Promising Phase I/II Data for Nectin-4 ADC Bulumtatug Fuvedotin in Cervical Cancer at ESMO-GC
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) announced the presentation of compelling clinical data for...
Innovent Biologics Doses First Patient in Pivotal Phase III Trial for IBI3003 Trispecific Antibody in Relapsed/Refractory Multiple Myeloma
Innovent Biologics (HKG: 1801) announced the first subject dosing in the pivotal Phase III TriadicMM-1...
CureGene Pharmaceutical Initiates Pivotal US Clinical Trial for Evategrel, World’s First Dual-Formulation P2Y12 Inhibitor Addressing Clopidogrel Resistance
Shanghai CureGene Pharmaceutical Co., Ltd. announced the enrollment of the first patient in a pivotal...
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...
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...