Mabwell Bioscience Secures NMPA Approval for 9MW5211 Clinical Trial in Multiple Sclerosis – Expanding Autoimmune Pipeline
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) announced that China’s National Medical Products Administration (NMPA)...
Drug
Takeda Secures NMPA Approval for Adzynma – China’s First Recombinant ADAMTS13 Therapy for Congenital TTP
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that China’s National Medical Products Administration...
Gilead’s Trodelvy (Sacituzumab Govitecan) Secures European Commission Approval for First-Line Metastatic TNBC – Expanding ADC Access to Treatment-Naïve Patients
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the European Commission (EC) has granted marketing authorization...
Henlius and Organon Canada Launch Denosumab Biosimilars BILDYOS and TUZEMTY – Expanding Access to Bone-Targeted Therapies Across All Canadian Indications
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon Canada announced the official commercial launch of...
AbbVie’s SKYRIZI (Risankizumab) Secures European Commission Approval for Pediatric Plaque Psoriasis – First IL-23 Inhibitor Authorized for Children as Young as Six
AbbVie Inc. (NYSE: ABBV) announced that the European Commission (EC) has granted marketing authorization for...
Sanofi’s Wayrilz (Rilzabrutinib) Secures Japanese Approval for Immune Thrombocytopenia – Expanding Global Footprint Across Six Major Markets
Sanofi S.A. (NASDAQ: SNY) announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved...
Mabwell Secures NMPA Clinical Trial Approval for 6MW5311 Bispecific Antibody – Dual US-China Authorization for Hematological Malignancies
Mabwell Bioscience Co., Ltd. (HKG: 2493) announced that China’s National Medical Products Administration (NMPA) has...
Ab&B Bio-Tech Secures NMPA Clinical Trial Approval for mRNA Mpox Vaccine – First Dual-Approved Candidate Globally
Ab&B Bio-Tech Co., Ltd. (HKG: 2627) announced that China’s National Medical Products Administration (NMPA) has...
China Medical System’s Silvemimab Becomes World’s First Dual-Epitope Fully Human Rabies Antibody Approved in China
China Medical System Holdings Limited (HKG: 0867) announced that the National Medical Products Administration (NMPA)...
Biokin Secures World’s First EGFR×HER3 Bispecific ADC Approval with Loncomystatug Deruxtecan for Nasopharyngeal Carcinoma
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that its first-in-class (FIC) Class 1 therapeutic...
Pierre Fabre Secures European Commission Approval for Braftovi Combination in BRAF-Mutant Colorectal Cancer
Pierre Fabre announced that the European Commission (EC) has approved Braftovi (encorafenib) in combination with...
Hengrui’s Rezvilutamide Receives EMA Acceptance for Metastatic Prostate Cancer Treatment
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the European Medicines Agency...
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)...
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...