China’s CDE Approves Multitude Therapeutics’ AMT-676 for Clinical Study in Solid Tumors
The Center for Drug Evaluation (CDE) of China has granted clinical study approval for Multitude...
Drug
Mabwell Bioscience Initiates Phase III Trial for 9MW2821 Combo in Urothelial Carcinoma Following NMPA Clearance
Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has announced...
US FDA Approves Updated COVID-19 mRNA Vaccines from Pfizer/BioNTech and Moderna Ahead of Winter
The U.S. Food and Drug Administration (FDA) has granted approval to two updated mRNA COVID-19...
Shouyao Holdings Receives Clinical Trial Approval for SY-7166 in Treating Multiple Myeloma
Shouyao Holdings (Beijing) Co., Ltd, a biopharmaceutical company headquartered in Beijing and listed on the...
Takeda Prepares to File Dengue Fever Vaccine for US Approval, Expanding Global Regulatory Reach
Takeda Pharmaceutical, a leading Japanese pharmaceutical company listed on the NYSE (NYSE: TAK), is reportedly...
Henlius Biotech’s Biosimilar Herceptin Approved by Health Canada for Breast and Gastric Cancer Treatments
Shanghai Henlius Biotech Inc., a leading biopharmaceutical company based in China and listed on the...
Jiangsu Simcere Pharmaceutical Gets NMPA Green Light for SIM0508 Clinical Trial in Advanced Solid Tumors
Jiangsu Simcere Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Hong Kong (HKG: 2096),...
Mabwell Bioscience Receives Approval for Phase III Trial of 9MW2821 in Cervical Cancer from China’s CDE
Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has received...
Gene Cradle Initiates First Regulatory Gene Therapy Study in China for Late-Onset Pompe Disease
Gene Cradle, a Beijing-based gene therapy specialist, has achieved a milestone by administering its GC301...
Phase I Success for Shandong Xinhua’s OAB-14, Advancing to Phase IIa in Alzheimer’s Therapy
Shandong Xinhua Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Shenzhen (SHE: 000756), has...
Hunan Warrant Pharmaceutical’s ZG-002 Receives NMPA Approval for Clinical Trials in Plaque Psoriasis
Hunan Warrant Pharmaceutical Co., Ltd, a pharmaceutical company based in China and listed on the...
UK MHRA Approves Eisai and Biogen’s Alzheimer’s Drug Leqembi, Despite NICE Reimbursement Rejection
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for Leqembi (lecanemab),...
Everest Medicines Launches Trial for Personalized mRNA Cancer Vaccine EVM16 in Solid Tumors
Everest Medicines, a biopharmaceutical company based in China and listed on the Hong Kong Stock...
Regeneron’s Linvoseltamab Faces FDA Complete Response Letter, Awaiting Reinspection of Manufacturer
Regeneron Pharmaceuticals Inc., a leading biopharmaceutical company based in the US and listed on the...
CK Life Sciences’ Halneuron Receives FDA Fast-Track Designation for Chemotherapy-Induced Neuropathic Pain
CK Life Sciences (HKG: 0775), a biopharmaceutical company headquartered in China, has received fast-track designation...
Innovent Biologics’ Fulzerasib Receives NMPA Approval for Advanced NSCLC Treatment in China
Innovent Biologics Inc., a biopharmaceutical company based in China and listed on the Hong Kong...
Qilu Pharmaceutical’s Biosimilar Ranibizumab Receives NMPA Approval, Marking a First in China
Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster...
BrightGene Bio Receives FDA Clearance for Generic Eribulin APIs, Advancing in Breast Cancer Treatment
BrightGene Bio-Medical Technology Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange...
Daiichi Sankyo Launches Tarlige for Diabetes Peripheral Neuropathic Pain in China
Daiichi Sankyo (TYO: 4568), a leading Japanese pharmaceutical company, has announced the official market launch...
Akeso Biopharma’s Ivonescimab Earns Category 1 Recommendation in China’s 2024 Lung Cancer Clinical Guideline
Akeso Biopharma, a China-based pharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 9926),...