Suzhou GenAssist’s GEN6050X Receives FDA Clearance for Duchenne Muscular Dystrophy Treatment
China-based Suzhou GenAssist Therapeutic Co., Ltd has announced receiving clearance from the US Food and...
Drug
BioRay Biopharmaceutical’s BR111 Receives NMPA Clearance for Clinical Trials in ROR1-Positive Malignancies
Zhejiang-based BioRay Biopharmaceutical has announced receiving clearance from the National Medical Products Administration (NMPA) to...
CStone Pharmaceuticals’ CS5001 Enters Phase Ib Trial for Diffuse Large B-Cell Lymphoma
China-based CStone Pharmaceuticals (HKG: 2616) has announced a Phase Ib clinical filing in Australia for...
Roche’s Gazyva Receives FDA Review Acceptance for Lupus Nephritis Treatment
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the US Food and...
Ascentage Pharma’s Olverembatinib Receives Third BTD in China for Ph+ ALL Treatment
China-based Ascentage Pharma (HKG: 6855) has announced that the Center for Drug Evaluation (CDE) of...
ImmuneOnco’s Timdarpacept (IMM01) and IMM2510 Receive NMPA Approval for Clinical Study in Advanced Malignant Tumors
China-based ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541) has received approval from the National Medical Products...
CSPC Pharma’s JMT108 Receives NMPA Clinical Approval for Advanced Malignant Tumors
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced clinical approval from the National Medical...
Antengene’s Xpovio Receives Marketing Approval in Indonesia
China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced receiving marketing approval in Indonesia for its...
RongCan Biotech’s mRNA HPV Vaccine Receives FDA Clinical Approval
China-based mRNA specialist RongCan (Shanghai) Biotech Co., Ltd announced that it has received clinical approval...
Zhejiang Huahai’s HB0034 Meets Primary Endpoint in GPP Study
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that its multi-center, double-blinded, randomized, placebo-parallel...
Fosun Pharma’s 24-Valent Pneumococcal Vaccine Receives NMPA Approval for Phase I Trial
China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd’s (SHA: 600196, HKG: 2196) subsidiary Fosun Adgenvax (Chengdu)...
Suzhou Abogen’s RSV mRNA Vaccine IND Approved by China’s CDE
China-based nucleic acid drug developer Suzhou Abogen Biosciences announced that the Investigational New Drug (IND)...
BeiGene’s Tevimbra Receives FDA Approval for ESCC Treatment
BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), a multinational oncology company planning to change...
AstraZeneca and Daiichi Sankyo’s Enhertu Shows Positive Results in Phase III Study
Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced positive topline results from the...
Genentech’s TNKase Approved by FDA for Acute Ischemic Stroke Treatment
Genentech, a subsidiary of Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), announced that its thrombolytic...
Eisai’s Lecanemab Rejected by Australia’s TGA for Early Alzheimer’s Treatment
Japan-based Eisai Co., Ltd (TYO: 4523) announced that the Therapeutic Goods Administration (TGA) of Australia...
Fapon Biopharma’s FP008 Receives FDA Approval for Clinical Trials
China-based Fapon Biopharma announced that it has received clinical trial approval from the US Food...
GSK’s Depemokimab Accepted for FDA Review as Ultra-Long-Acting Biologic
GSK plc (LON: GSK, NYSE: GSK) announced that the US Food and Drug Administration (FDA)...
Juvestar and Raziel Therapeutics Launch Phase III Study for RZL-012 in China
Juvestar Biotech Co., Ltd., a subsidiary of China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA:...
Zai Lab’s Augtyro Receives TFDA Approval for ROS1-Positive NSCLC and NTRK Fusion Solid Tumors
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received marketing...