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420,352 Results for "australian therapeutic goods administration".
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OS Therapies Granted Meetings with U.S. FDA, U.K. MHRA, EMA and Australian Therapeutic Goods Administration to Review Global Confirmatory Phase 3 Trial for OST-HER2 in Metastatic Osteosarcoma
• Meetings with all four regulatory agencies scheduled to occur in the second quarter of 2026, with expected Phase 3 commencement in the third quarter of 2026 initially in Australia • Commencing the Phase 3 confirmatory study is a pre-requisite to being granted a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisations (CMAs) in the U.K. & Europe
March 27, 2026
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5 min read
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Moderna Receives Australian Therapeutic Goods Administration Approval for RSV Vaccine for Older Adults
April 1, 2025
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CAMP4 Therapeutics Secures Australian Regulatory Clearance to Initiate First-in-Human Clinical Trial of CMP-002 in Patients With SYNGAP1-Related Disorder
July 27, 2026
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Lōkahi Therapeutics™ Advances LT-100 Development Strategy Toward Single-Injection Administration
July 29, 2026
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bioLytical’s iStatis Syphilis Antibody Test Now Included in the Australian Register of Therapeutic Goods (ARTG)
October 13, 2025
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Grace Therapeutics Announces Receipt of Type A Meeting Minutes from U.S. Food and Drug Administration
July 28, 2026
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10 min read
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Oragenics Achieves Full Activation of Australian Phase IIa Trial Network — All Three Sites Now Enrolling
July 7, 2026
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FibroBiologics Files Patent Application for Oral Administration of Fibroblast Therapeutics
May 18, 2026
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Marvel Biosciences Receives Notice of Allowance for Australian Patent Application Covering Composition of Matter for its Lead Therapeutic Candidate MB-204
June 8, 2026
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Anixa Biosciences Expands Global Patent Portfolio with Australian Patent Acceptance for Breast Cancer Vaccine Technology
July 14, 2026
·
5 min read
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