Roche’s Phesgo and Faricimab Receive NMPA Approvals for Breast Cancer and nAM
The National Medical Products Administration (NMPA) has granted separate approvals for two distinct drugs from...
Drug
BeiGene’s Tislelizumab Secures 12th Indication Approval in China for HCC First-Line Treatment
BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received approval...
BMS’ Augtyro Receives EMA Review for Advanced Lung Cancer and Solid Tumors Treatments
The European Medicines Agency (EMA) has accepted for review a filing submitted by Bristol Myers...
Huadong Medicine Ends Collaboration on vTv’s TTP273 for Diabetes Treatment
US-based vTv Therapeutics LLC has received a cancellation notice from China’s Huadong Medicine Co., Ltd.,...
Jiangsu Recbio’s REC610 Shingles Vaccine Shows Positive Results in First-In-Human Study
Jiangsu Recbio Technology Co., Ltd (HKG: 2179), a Chinese biotechnology company, has announced positive results...
Innovent Biologics Initiates Phase III Trial for Mazdutide in Obesity Treatment
Innovent Biologics Inc., a biopharmaceutical company based in China (HKG: 1801), has announced the first...
Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Gets US FDA Approval for Clinical Trials
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it...
Boan Biotech Secures FDA Orphan Drug Designations for Pancreatic Cancer Treatments
China-based Boan Biotech (HKG: 6955) has announced that its novel antibody BA1105 and antibody-drug conjugate...
Gilead’s Kite Receives FDA Nod to Add Overall Survival Data to Yescarta for Large B-Cell Lymphoma
Gilead Sciences Inc. (NASDAQ: GILD) subsidiary Kite has received approval from the U.S. Food and...
FDA Prioritizes Roche’s Xolair for Food Allergy Indication Extension Ahead of Q1 Decision
The U.S. Food and Drug Administration (FDA) has prioritized Roche’s (SWX: ROG) indication extension filing...
Lepu Biotechnology Completes Enrollment for Phase IIb Trial of MRG003 in Nasopharyngeal Carcinoma
Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced the completion of subject...
Shanghai Henlius Secures Indonesian Approval for HanSiZhuang in Small-Cell Lung Cancer
Shanghai Henlius Biotech Inc. (HKG: 2696) has received market approval from the Indonesian Food and...
Clover Biopharma’s SCB-219M Shows Promising Phase I Results for Chemotherapy-Induced Thrombocytopenia
Clover Biopharmaceuticals Ltd (HKG: 2197), based in China, has announced promising preliminary results from its...
Fosun’s HLX42 Receives Fast-Track Designation from FDA for NSCLC Treatment
Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196; SHA: 600196) has announced that its antibody-drug conjugate...
Simcere Secures Approval for Local Manufacturing of Cosela, Boosting Patient Access
China-based Simcere Pharmaceutical Group (HKG: 2096) has received supplementary filing approval for its drug Cosela...
Sanofi Gains NMPA Approval for Innovative Rosuvastatin and Ezetimibe Combination Therapy
Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced that it has received market approval...
AstraZeneca Secures FDA Approval for Self-Administered hATTR-PN Therapy Wainua
AstraZeneca (AZ, NASDAQ: AZN), headquartered in the UK, announced last week that the U.S. Food...
Taiwan FDA Reviews Nefecon New Drug Application from Everest Medicines
China-based Everest Medicines (HKG: 1952) has announced that the New Drug Application (NDA) for Nefecon...
Amgen’s Lumakras Faces Full Approval Delay as FDA Requests New Study
The US Food and Drug Administration (FDA) has declined to grant full approval for Amgen’s...
Guangdong Zhongsheng Pharmaceutical’s ZSP1273 for Influenza A Accepted for Review by NMPA
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a Chinese pharmaceutical company, has announced that China’s...