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BioPharma Drug Approval

METiS TechBio’s AI-Designed MTS-004 Meets Phase III Success in China, Targeting Pseudobulbar Affect

MTS-004 Poised to Fill an Unmet Need in the Treatment of Pseudobulbar Affect (PBA) METiS TechBio, a global leader in AI-driven nanodelivery and formulatio...

October 24, 2025 | News

Alphamab Oncology and CSPC’s HER2-Targeting ADC JSKN003 Receives Breakthrough Therapy Designation in China for Advanced Colorectal Cancer

Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) jointly announced that biparatopic HER2-targ...

October 21, 2025 | News

Jacobio Pharma Partners with Oceanpine Capital in RMB 200 Million Equity Deal for Cardiovascular Research Subsidiary

Jacobio Pharma announced that its subsidiary, Beijing Jacobio Pharmaceuticals Co., Ltd. ("Beijing Jacobio"), has entered into a Capital Increase and Equity...

October 16, 2025 | News

Everest Medicines Secures Dual IND Approvals for EVM14, Its First Internally Developed Therapeutic mRNA Cancer Vaccine

EVM14 becomes Everest Medicines' internally developed therapeutic mRNA cancer vaccine to receive IND approvals from both China's National Medic...

October 14, 2025 | News

Jenscare’s LuX-Valve Plus Approved for Use in Greater Bay Area Under Hong Kong-Macao Medicine and Equipment Connect

Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company with comprehensive structural heart disease ...

October 13, 2025 | News

C-Ray Therapeutics Commends Biokin on NMPA Approval for Groundbreaking [177Lu]-BL-ARC001 Radiopharmaceutical

C-Ray Therapeutics (Chengdu) Co.,Ltd proudly congratulates its strategic partner, Biokin Pharmaceutical, on receiving implied approval from the N...

October 13, 2025 | News

Japan Grants National Reimbursement for MedHub-AI AutocathFFR Marking a Breakthrough in AI-Driven Coronary Physiology

MedHub-AI announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved national reimbursement for the company's Autoca...

October 06, 2025 | News

Celltrion Launches AVTOZMA IV FDA Approved Tocilizumab Biosimilar in United States

The AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation was approved in January 2025 by the FDA to treat the same conditions as t...

October 03, 2025 | News

Japan Grants Orphan Drug Designation to JR-446 for Sanfilippo Syndrome Type B

MEDIPAL HOLDINGS CORPORATION and JCR Pharmaceuticals Co., Ltd. announced that the Ministry of Health, Labour and Welfare of Japa...

October 01, 2025 | News

AbbVie Submits FDA Application for Tavapadon After Positive Phase 3 TEMPO Results in Parkinson’s Disease

Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's disease spectrum Positive r...

September 29, 2025 | News

Akeso Doses First Patient in Phase II Study of Novel TIGIT/TGF-β Bifunctional Antibody for Pancreatic Cancer

Akeso Inc. has announced that the first patient has been dosed in its registrational Phase II study (AK130-202), evaluating AK130, a fully independent...

September 23, 2025 | News

Sanofi and Regeneron Receive CHMP Recommendation for Dupixent in Chronic Spontaneous Urticaria in EU

Recommendation for adults and adolescents based on phase 3 studies showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo ...

September 23, 2025 | News

Ono Pharmaceutical Wins EU Approval for Vimseltinib as First TGCT Therapy

Vimseltinib is the first and only therapy with marketing authorization for the treatment of TGCT in the European Union Ono Pharmaceutical Co., a...

September 19, 2025 | News

US, China and Australia Begin Phase 2 Trial of Atom Therapeutics’ ABP-745 for Acute Gout Flares

ABP-745 is an oral small molecule drug with potential applications, for other inflammatory conditions such as cardiovascular disease Atom T...

September 17, 2025 | News

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