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BioPharma Drug Approval

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

JW Therapeutics Secures Macao Approval for CAR-T Therapy Carteyva®, Marking First Overseas Market Entry

JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunother...

June 05, 2025 | News

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