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Drug Approval

Everest Medicines Secures Full Taiwan Approval for NEFECON® in IgA Nephropathy

Everest Medicines (HKEX 1952.HK) recently announced the Taiwan Food and Drug Administration (TFDA) has approved the supplementary application for NEFECON(R...

August 12, 2025 | News

Bracco Imaging’s SonoVue® Gains NMPA Approval for HyCoSy Use in Infertility Diagnosis in China

Bracco Imaging, a global leader in diagnostic imaging,announced that its ultrasound contrast agent SonoVue® has been approved by the China's&...

August 06, 2025 | News

Chipscreen Biosciences Receives FDA IND Approval for Brain-Penetrant Aurora B Inhibitor CS231295

Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences") announced that its wholly owned subsidiary, Chipscreen Biosciences (USA) Ltd., has rec...

August 04, 2025 | News

Mabwell’s CDH17-Targeting ADC 7MW4911 Receives IND Clearance in China and U.S.

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its proprietary CDH17-targeting antibody-drug ...

August 04, 2025 | News

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

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