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BioPharma Drug Approval

Singapore Approves Dupixent as First Biologic Treatment for Uncontrolled COPD with Raised Eosinophils

The Health Sciences Authority (HSA) has approved Dupixent (dupilumab) for adults as an add-on maintenance treatment for uncontrolled chronic obstru...

May 14, 2025 | News

BioDlink Supports Junshi Biosciences in Achieving IND Approval for JS212, Its First Bispecific ADC

BioDlink congratulates Junshi Biosciences on receiving IND approval from China's NMPA for JS212, the company...

May 09, 2025 | News

China Grants Full Approval to Everest Medicines’ NEFECON® as First and Only Etiological Treatment for IgA Nephropathy

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

May 07, 2025 | Regulatory

IGI’s Trispecific Antibody ISB 2001 Receives FDA Fast Track Designation for Relapsed Multiple Myeloma

IGI, a global, fully integrated, clinical-stage biotechnology company focused on multi-species™ oncology product development, announced that th...

May 06, 2025 | News

Fangzhou Launches Otsuka’s Iclusig® Online for Leukemia Care in China

Fangzhou Inc. , a leader in Internet healthcare solutions, announced the availability of Otsuka Pharmaceutical's third-generation tyrosine kinase inhi...

May 06, 2025 | News

InnoCare’s Zurletrectinib Granted Priority Review in China for NTRK Fusion-Positive Solid Tumors

InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced that its new genera...

May 05, 2025 | News

S&E bio Receives MFDS Approval for Korea’s First Clinical Trial of Exosome-Based Stroke Therapy

S&E bio Co., Ltd., a biotechnology company specializing in exosomal microRNA-based therapies, has received approval from Korea's Ministry of Food...

May 01, 2025 | News

Everest Medicines Secures Hong Kong Approval for VELSIPITY® in Ulcerative Colitis

Everest Medicines , a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeu...

April 30, 2025 | News

Akeso’s Ivonescimab Outperforms Pembrolizumab in Phase III, Wins NMPA Approval for First-Line PD-L1-Positive NSCLC

Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that its globally first-in-class PD-1/VEGF bispecific antibody, ivonescimab, has re...

April 28, 2025 | News

Innovent Biologics Secures NMPA Approval for Limertinib as First-Line Therapy for EGFR-Mutated NSCLC in China

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...

April 28, 2025 | News

Primo Biotechnology Secures PIC/S GMP and GDP Certifications, Strengthening Global Position in Nuclear Medicine

Primo Biotechnology Co., Ltd. ("Primo") proudly announces that its Taoyuan pharmaceutical facility has successfully passed inspection by Taiwan Food and Dr...

April 25, 2025 | News

Sun Pharma and Moebius Medical Showcase Durable Pain Relief and Cartilage Protection with MM-II for Knee Osteoarthritis

Durable pain relief from a single MM-II injection and its cartilage-protective effects in OA models featured in two peer-reviewed articles - - New d...

April 25, 2025 | News

Onward Therapeutics Receives EMA Green Light for Phase 1 Trial of Allogeneic NK Cell Therapy in Relapsed DLBCL

Onward Therapeutics SA, a biotechnology company dedicated to advancing innovative cancer immunotherapies, announced that its subsidiary, Emercell SAS, has ...

April 23, 2025 | News

Sichuan Kelun-Biotech Secures FDA IND Clearance for First-in-Class ADC SKB518

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company has been granted the clearance of investigational new dru...

April 22, 2025 | News

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