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Drug Approval

Ractigen Therapeutics Receives FDA Orphan Drug Designation for RAG-21, a Novel siRNA Therapy for FUS-ALS

Ractigen Therapeutics, a clinical-stage pharmaceutical company dedicated to developing innovative therapies, announced that the U.S. Food and Drug Administ...

November 20, 2024 | News

Epigenic Therapeutics Secures Approval in New Zealand for World’s First Epigenetic Therapy Clinical Trial for Chronic Hepatitis B

Epigenic Therapeutics, a leading biotechnology company dedicated to developing next-generation gene modulation therapy, announced that it has received appr...

November 20, 2024 | News

Everest Medicines' NEFECON® Gains Full Approval in South Korea for IgA Nephropathy Treatment

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...

November 19, 2024 | News

Acepodia Secures FDA IND Clearance for ACE1831, Pioneering Gamma Delta T Cell Therapy in Autoimmune Disease

IND clearance paves the way for Acepodia to enter the clinic for the first time with its autoimmune program ACE1831 is an allogeneic gamma delta T...

November 18, 2024 | News

Ascentage Pharma’s Lisaftoclax NDA Accepted for Priority Review in China: A Potential First for Bcl-2 Inhibitors

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unm...

November 18, 2024 | News

Mabwell's Nectin-4 Targeting ADC Secures IND Approval for Clinical Trials in Perioperative Urothelial Carcinoma and Advanced Solid Tumors

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its novel Nectin-4 targeting ADC (R&D code: 9MW...

November 15, 2024 | News

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

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