BioPharma Drug Approval
BON Natural Life Launches AI-Powered Drug Discovery Platform, Advancing TCM-Based Pharma Innovation
Bon Natural Life Limited (Nasdaq: BON) ("BON" or "the Company"), a leading provider of bio-ingredient solutions for the natural health and personal care in...
July 31, 2025 | News
Sirtex Secures FDA Approval for SIR-Spheres® Y-90 in Treating Unresectable Hepatocellular Carcinoma
Sirtex Medical ("Sirtex"), a leading manufacturer of interventional oncology solutions, today announced that the U.S. Food and Drug Administration (F...
July 08, 2025 | News
Celltrion Launches STOBOCLO® and OSENVELT® Biosimilars in the U.S. for Comprehensive Bone Health and Oncology Care
STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of PROLIA® (denosumab) and X...
July 08, 2025 | News
ImmunityBio Secures First International Approval for ANKTIVA® in the UK for Bladder Cancer Treatment
ANKTIVA, a first-in-class, lymphocyte-stimulating agent, works synergistically with BCG to activate and proliferate natural killer (NK) and T cells, he...
July 08, 2025 | News
Clasado Biosciences Gains TGA Approval for Bimuno® GOS in Australia’s Therapeutic Supplement Market
Clasado Biosciences has announced that its prebiotic ingredient Bimuno® GOS is now available for use in Therapeutic Goods Administration (TGA)-listed p...
July 07, 2025 | News
Dizal Secures FDA Approval for ZEGFROVY, the First Targeted Oral Therapy for EGFR Exon20ins NSCLC
ZEGFROVY is the only approved targeted oral treatment for NSCLC with EGFR exon20ins Approval follows the U....
July 03, 2025 | News
Switzerland’s RDP Pharma and Singapore’s A*STAR EDDC Join Forces to Develop Precision Autoimmune Therapies
RDP Pharma AG, a Swiss biotechnology company focused on next-generation protein degradation therapeutics, and the Experimental Drug Development...
July 02, 2025 | News
Innovent Biologics Secures NMPA Approval for World’s First Dual GCG/GLP-1 Receptor Agonist Mazdutide for Weight Management in China
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...
June 30, 2025 | News
Daiichi Sankyo and AstraZeneca’s DATROWAY Receives U.S. FDA Accelerated Approval for EGFR-Mutated Lung Cancer
Based on TROPION-Lung05 phase 2 trial results and supported by data from the TROPION-Lung01 phase 3 trial Second U.S. approval for Daiichi Sankyo and ...
June 24, 2025 | News
RemeGen’s Telitacicept Secures EMA Orphan Drug Designation for Myasthenia Gravis, Advancing Global Development
RemeGen Co., Ltd. ("RemeGen", stock symbols: 688331.SH/09995.HK) announced that telitacicept (RC18; brand name: 泰爱®) has received Orphan Drug Desig...
June 18, 2025 | News
Harrow Secures Exclusive U.S. Rights to BYQLOVI for Post-Surgical Eye Care Following FDA Approval
Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, and Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW), today a...
June 10, 2025 | News
ZEISS CLARUS® 700 Receives NMPA Approval in China, Enhancing Retinal Diagnostics
ZEISS Medical Technology announced that the CLARUS® 700 from ZEISS has received National Medical Products Administration (NMPA) approval in China,...
June 06, 2025 | News
Innovent and HUTCHMED’s Sintilimab-Fruquintinib Combo Accepted for NMPA Review in Advanced Renal Cell Carcinoma
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality me...
June 05, 2025 | News
Innovent Secures Second NMPA Breakthrough Therapy Designation for IBI363 in Advanced Lung Cancer
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality m...
June 05, 2025 | News
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