Merck Secures FDA Approval for Keytruda-Welireg Combination as Adjuvant Therapy in High-Risk Kidney Cancer
Merck & Co., Inc. (MSD; NYSE: MRK) announced that the U.S. Food and Drug Administration...
Drug
Simcere Pharmaceutical Secures NMPA Approval for SIM0689 Bispecific Antibody Targeting PD-1 and VEGF in Solid Tumors
Simcere Pharmaceutical Group (HKG: 2096) announced that SIM0689, a novel bispecific antibody (BsAb) targeting both...
Mabwell Bioscience Secures FDA Approval for 6MW5311 Bispecific Antibody Trial in Hematologic Malignancies
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) announced that the U.S. Food and Drug Administration...
Merck Secures NMPA Approval for Enflonsia (Clesrovimab) – First Single-Dose RSV Monoclonal Antibody in China
Merck & Co., Inc. (MSD, NYSE: MRK) announced that China’s National Medical Products Administration (NMPA)...
Shouyao Holdings Secures NMPA Approval for Second-Generation ALK Inhibitor CT-707 as First-Line Treatment for ALK-Positive NSCLC
Shouyao Holdings (Beijing) Co., Ltd. (SHA: 688197), a Beijing-based pharmaceutical company, announced it has received...
Createrna’s MY008211A Becomes China’s First Home-Grown Oral CFB Inhibitor Approved for Paroxysmal Nocturnal Hemoglobinuria
Wuhan Createrna Science and Technology Co., Ltd., a China-based biopharmaceutical company, announced it has received...
Takeda’s Zasocitinib Demonstrates Superior Efficacy Over Deucravacitinib in Phase III Psoriasis Trial with 35% PASI 100 Response Rate
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced positive topline results from a Phase...
LongBio Pharma’s Anti-IgE Antibody LP-003 Meets Primary Endpoint in Phase III Seasonal Allergic Rhinitis Trial
LongBio Pharma (HKG: 1779), a China-based biomacromolecule drug developer, announced that the Phase III clinical...
Novartis’ Del-Brax Meets Primary Endpoints in FSHD Biomarker Study – Potential First Disease-Modifying Therapy for Rare Muscular Dystrophy
Novartis AG (NYSE: NVS) announced that the biomarker cohort of the FORTITUDE Phase I/II clinical...
Novartis Secures Fourth China Approval for Tafinlar-Mekinist Combo in BRAF V600E-Mutated Radioactive Iodine-Refractory Differentiated Thyroid Cancer
Novartis AG (NYSE: NVS) announced that China’s National Medical Products Administration (NMPA) has granted approval...
Yipinhong Pharmacy Receives NMPA Clearance for APH03571 Dual-Mechanism Therapy in FLT3-Mutated Relapsed/Refractory AML
Yipinhong Pharmacy Co., Ltd. (SHE: 300723) announced it has received Investigational New Drug (IND) clearance...
CSPC Pharmaceutical’s Phase III Trial of Anbenitamab-Docetaxel Combination Meets Primary Endpoint in First-Line HER2-Positive Advanced Breast Cancer
CSPC Pharmaceutical Group (HKG: 1093) announced that its Phase III clinical trial evaluating Ennituo (anbenitamab)...
Imviva Biotech Receives FDA Clearance for Phase 1b Basket Trial of CTA313 Allogeneic CAR-T Therapy in B Cell-Mediated Autoimmune Diseases
Imviva Biotech announced it has received Investigational New Drug (IND) clearance from the U.S. Food...
Akeso Biopharma Secures NMPA Approval for Gumokimab, IL-17A Monoclonal Antibody for Moderate-to-Severe Plaque Psoriasis
Akeso Biopharma (HKG: 9926) announced it has received marketing approval from China’s National Medical Products...
Hansoh Pharmaceutical’s NDA for HS-10568 Calcium-Sensing Receptor Modulator Accepted by China’s NMPA for Secondary Hyperparathyroidism in Dialysis Patients
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China’s National Medical Products Administration (NMPA)...
Bio-Thera Solutions Secures Singapore Approval for BAT2206, Biosimilar to J&J’s Stelara, Expanding Access Across Multiple Autoimmune Indications
Bio-Thera Solutions Ltd. (SHA: 688177) announced it has received marketing approval from Singapore’s Health Sciences...
PKU Hi-Tech Huatai Pharmaceuticals Blacklisted from China’s Volume-Based Procurement Following Quality Compliance Failures
PKU Hi-Tech Huatai Pharmaceuticals Co., Ltd. has been blacklisted from China’s national volume-based procurement (VBP)...
Sanofi Halts Phase 3 MOBILIZE Trial for Riliprubart in Refractory CIDP Patients Following Interim Analysis
Sanofi (NASDAQ: SNY) announced the discontinuation of its MOBILIZE phase 3 clinical trial evaluating riliprubart...
NeuroGen Pharma Secures NMPA Approval for Ajovy (Fremanezumab) in China, Launching First Quarterly CGRP Migraine Prevention Therapy
NeuroGen Pharma announced it has received marketing approval from China’s National Medical Products Administration (NMPA)...
Harbour BioMed’s TSLP Inhibitor HBM9378/WIN378 Doses First Patient in Phase II COPD Study with Windward Bio, Supporting Twice-Yearly Dosing Regimen
Harbour BioMed (HKG: 2142) announced that the first patient has been dosed in the Phase...