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Drug Approval

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

Pfizer Advances Australian-Discovered KAT6 Inhibitor PF-07248144 into Phase 3 Trial for Advanced Breast Cancer

Australian biotechnology investment and commercialisation incubator, Oncology One Pty Ltd, is pleased to report that PF-07248144, Pfizer Inc's clinica...

September 16, 2025 | News

Akeso Doses First Patient in Global Phase II Registrational Trial of Cadonilimab Plus Lenvatinib for IO-Pretreated Advanced HCC

Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its global, multicenter, randomized Phase II regi...

September 16, 2025 | News

Biostar Pharma Doses First Patients in Two Global Phase II/III Trials of Oral Utidelone Capsule for Gastric and Ovarian Cancers

Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. ("Biostar", Stock Code: 2563.HK) which is a synthetic biolo...

September 16, 2025 | News

BioAge Advances BGE-102 into Phase 1 Trials Triggering Milestone Payment to HitGen as DEL Technology Accelerates Drug Discovery

BGE-102, an orally available, brain-penetrant NLRP3 inhibitor, was developed from a hit compound identified using HitGen's industry-leading DEL technolog...

September 16, 2025 | News

Alphamab Oncology’s NDA for KN026 Accepted by NMPA for HER2-Positive Gastric Cancer

Alphamab Oncology announced that the New Drug Application (NDA) for anbenitamab injection (KN026), independently developed by the Company and co-developed ...

September 15, 2025 | News

China Grants First Approval for Tzield to Delay Onset of Type 1 Diabetes

Approval based on the TN-10 study, demonstrating Tzield’s ability to delay the onset of stage 3 T1D in adult and pediatric patients aged eight year...

September 11, 2025 | News

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