Drug Approval
Harbour BioMed Files IND Application in China for Novel Antibody Therapy HBM9378/SKB378 Targeting COPD
Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel ant...
November 11, 2024 | News
Dizal Submits NDA to U.S. FDA for Sunvozertinib as a New Treatment Option for Advanced NSCLC with EGFR Exon 20 Insertion Mutations
Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announ...
November 11, 2024 | News
China’s Leads Biolabs Secures FDA Orphan Drug Designation for LBL-034 in Multiple Myeloma Treatment
Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs") announced that LBL-034, a humanized bispecific T-cell engaging antibody target...
November 07, 2024 | News
DX&VX Selected for South Korea's ARPA-H Project to Pioneer Room-Temperature mRNA Vaccine Storage
Pioneering Korea's ARPA-H Project: Focused on mRNA Vaccine Room-Temperature Storage and Extra-Long-Term Preservation Creating a Platform for Prolonged R...
November 04, 2024 | News
Chipscreen Biosciences Secures NMPA Approval for Phase III Trial of Chiauranib in ES-SCLC Treatment
Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as "Chipscreen Biosciences") and its wholly-owned subsidiary Chengdu Chipscreen Ph...
November 04, 2024 | News
Taiwan’s CStone Secures UK Approval for Sugemalimab as First-Line Treatment for Metastatic NSCLC
This approval marks the second international marketing authorization for sugemalimab outside of China, following its recent approval by the Eur...
November 01, 2024 | News
Hong Kong Approves Eli Lilly’s Mounjaro® as First Dual-Receptor Agonist for Obesity and Type 2 Diabetes
Adults taking Mounjaro in a clinical trial lost on average 48 lb. at the highest dose1,2 Mounjaro delivered superior A1C reductions versus all comparato...
October 28, 2024 | News
MicuRx Achieves Milestone with Successful Phase I Trial of Novel Antibacterial MRX-5 in Australia
Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH) announced the successful completion of Phase I clinical trial of MRX-5 in Australi...
October 28, 2024 | News
Everest Medicines’ VELSIPITY® Approved for Ulcerative Colitis in Greater Bay Area Hospitals under "Hong Kong and Macau Medicine Connect" Policy
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...
October 25, 2024 | News
EpiVax and CUBRC Secure $2M FDA Contract to Develop T Cell Assay Standards for Generic Drug Immunogenicity
EpiVax, Inc. ("EpiVax") and CUBRC, Inc. ("CUBRC") announce that they have been awarded a two-year, $2 million contract (#75F40124C00094) from the...
October 25, 2024 | News
Australia's Telix Pharmaceuticals Secures FDA Priority Review for Pixclara® (TLX101-CDx) Glioma Imaging Agent
Telix Pharmaceuticals announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ...
October 24, 2024 | News
SK bioscience Gains Approval for SKYCellflu in Indonesia, Expanding Global Reach for Cell-Cultured Influenza Vaccines
This approval paves the way for exports to the world's fourth most populous country. SK bioscience aims to continue to grow as a global vaccine brand be...
October 23, 2024 | News
South Korea Approves XPOVIO® for Third Indication in Multiple Myeloma Treatment
This approval for XPOVIO® for the treatment of patients with multiple myeloma (MM) marks the third approved indication of the drug in South...
October 21, 2024 | News
Everest Medicines Gains TFDA Approval for NEFECON® to Treat IgA Nephropathy in Taiwan
Everest Medicines , a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeut...
October 21, 2024 | News
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