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BioPharma Drug Approval

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

Rona Therapeutics Secures IND Approval in China for siRNA-Based Hypertension Therapy RN1871

Rona Therapeutics, a biotechnology company pioneering innovative RNA-targeted therapies, announced that the Investigational New Drug (IND) application for&...

April 22, 2025 | News

Akeso Secures NMPA Approval for Ebdarokimab in Moderate-to-Severe Plaque Psoriasis

Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that ebdarokimab, an investigational monoclonal antibody developed by the company, ...

April 21, 2025 | News

TGA Approves IFINWIL® for High-Risk Neuroblastoma Treatment in Australia

Norgine is pleased to announce that the Australian Therapeutic Goods Administration (TGA) has approved the registration of IFINWIL® (eflornit...

April 17, 2025 | Regulatory

Bristol Myers Squibb’s Opdivo Plus Yervoy Wins FDA Nod as First-Line Treatment for Advanced Liver Cancer

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy® ...

April 14, 2025 | News

Halozyme and argenx Secure FDA Nod for VYVGART® Hytrulo Prefilled Syringe for Self-Injection

Halozyme Therapeutics, Inc. announced that argenx has received U.S. Food and Drug Administration (FDA) approval of VYVGART® Hytrulo prefilled syri...

April 11, 2025 | News

Belief BioMed and Takeda China Announce NMPA Approval of China’s First Gene Therapy for Hemophilia B

Belief BioMed ("BBM") and Takeda China jointly announced that BBM-H901 (generic name: Dalnacogene Ponparvovec Injection), has be...

April 11, 2025 | News

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