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BioPharma Drug Approval

Taiwan's Caliway Biopharmaceuticals Receives EMA Orphan Drug Designation for CBL-514 in Dercum’s Disease Treatment

CBL-514 is the first and only drug to receive EMA Orphan Drug Designation for Dercum's disease treatment.- CBL-514 received both FDA Orphan Drug...

November 14, 2024 | News

Alphamab Oncology’s JSKN033 Receives Fast-Track Approval from Shanghai Drug Authority for Innovative Cancer Therapy Clinical Trials

Alphamab Oncology (stock code: 9966.HK) announced that a clinical trial (Study ID: JSKN033-102) of JSKN033, a high-concentration subcutaneous co-formulatio...

November 13, 2024 | News

Nordic Bioscience Secures FDA Letter of Support for CPa9-HNE Biomarker in Advancing IBD Clinical Trials

Nordic Bioscience, a leading biomarker company, announced that its CPa9-HNE biomarker assay received a Letter of Support (LoS) from the U.S. Food and Drug ...

November 12, 2024 | News

Australia’s Neurizon Therapeutics Secures Positive EMA Opinion for Orphan Medicinal Product Designation of NUZ-001 in ALS

Notice of positive opinion received from the European Medicines Agency for Orphan Medicinal Product Designation for NUZ-001 in Amyotrophic Lateral S...

November 12, 2024 | News

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

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