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Australia

Japan Grants Orphan Drug Designation to Lundbeck’s Amlenetug for Multiple System Atrophy

The Ministry of Health, Labor, and Welfare (MHLW) in Japan has granted Orphan Drug Designation (ODD) to Lundbeck's investigational drug, amlenetu...

March 11, 2025 | News

CStone Pharmaceuticals Advances CS5001 with Phase Ib Trial Application in Australia for First-Line DLBCL Treatment

Phase Ib trial to evaluate CS5001 in combination with R-CHOP as a first-line treatment for diffuse large B-cell lymphoma (DLBCL), aiming to reshape ...

March 06, 2025 | News

Avecho and Sandoz Ink 10-Year Deal for Australia’s First Pharmaceutical CBD Capsule for Insomnia

Avecho and Sandoz sign an exclusive ten-year development and license agreement ("Agreement") for Avecho's pharmaceutical cannabidiol capsule for insomnia...

March 04, 2025 | News

Neopharma Partners with AusChain to Enable Blockchain-Powered Drug Test Kit Traceability

Neopharma Technologies Ltd (Neopharma) is pleased to announce a strategic partnership with AusChain Pty Ltd, a global leader in scalable blockchain so...

February 28, 2025 | News

Akeso Enrolls First Patient in Phase I Trial for HER3-Targeting ADC AK138D1 in Australia

Akeso, Inc. (9926.HK) announced the first patient has been enrolled in the Phase I clinical trial of AK138 D1 for the treatment of advanced malignancies in...

February 28, 2025 | News

Telix’s Kidney Cancer Imaging Agent Gains FDA Priority Review, Eyes 2025 Launch

Telix Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for TLX25...

February 26, 2025 | News

Thermo Fisher Scientific to Acquire Solventum’s Purification & Filtration Business for $4.1 Billion in Cash

Thermo Fisher Scientific Inc. (NYSE: TMO) (“Thermo Fisher”), the world leader in serving science, announced that the company has en...

February 25, 2025 | News

SK Bioscience Advances mRNA Vaccine for Japanese Encephalitis with Phase 1/2 Trials in Australia and New Zealand

SK bioscience’s first mRNA vaccine candidate enters Phase 1/2 clinical trials in Australia and New Zealand, with interim results expected by 2026. ...

February 25, 2025 | News

LabConnect and ACL Specialised Trials Partner to Strengthen Clinical Trial Support in Australia and APAC

LabConnect and Australian Clinical Labs' (ACL) Specialised Trials have forged a strategic partnership to expand support of clinical trials in Aus...

February 25, 2025 | News

Australia Grants First Global Market Approval for YORVIPATH® to Treat Chronic Hypoparathyroidism

YORVIPATH® (palopegteriparatide) is now registered by the Therapeutic Goods Administration (TGA) for the treatment of chronic hypoparathyroidism...

February 21, 2025 | News

Australia’s Clarity Pharmaceuticals Secures FDA Fast Track for 67Cu-SAR-bisPSMA in Prostate Cancer

Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation pr...

February 20, 2025 | News

Australia’s Navi Medical Technologies secures FDA clearance for Neonav ECG Tip Location System expanding pediatric vascular access in the US Victoria and globally

Navi Medical Technologies has announced that its Neonav® ECG Tip Location System has received 510(k) clearance from the U.S. Food and Drug Administrati...

February 17, 2025 | News

Australia's Telix Pharmaceuticals Secures MHRA Approval for Illuccix® Prostate Cancer Imaging Agent in the UK

Telix Pharmaceuticals Limited announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approve...

February 13, 2025 | News

Wellumio’s Portable MRI ‘Axana’ Begins First Clinical Study in Australia for Rapid Stroke Detection

Wellumio, a New Zealand-based medical device company pioneering advancements in stroke detection, today announced enrollment of the first patien...

February 07, 2025 | News

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