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Therapeutic Goods Administration

Pharma & Biotech

Incyte’s Minjuvi gains Australian reimbursement after TGA follicular lymphoma registration

Australia has listed Minjuvi on the PBS for relapsed follicular lymphoma. See what the inMIND data and access terms mean.

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Pharma & Biotech

CAMP4 clears Australian hurdle for first human CMP-002 study in SYNGAP1 disorder

CAMP4 gains Australian clearance for a Phase 1/2 CMP-002 trial targeting the genetic cause of SYNGAP1-related disorder.

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Pharma & Biotech

Arrowhead just unlocked Australia for REDEMPLO, but the bigger RNAi test starts now

Arrowhead has regulatory momentum in rare lipid disease. The harder test is turning REDEMPLO approval into durable global uptake.

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Pharma & Biotech

Vaxxas earns GMP licence for HD-MAP production—what this unlocks for clinical trials

Vaxxas Pty Ltd, the Australian biotechnology company known for its high-density microarray patch (HD-MAP) platform, has secured a manufacturing licence from the Therapeutic Goods Administration (TGA) to produce its investigational vaccine delivery system under Good Manufacturing Practice (GMP) conditions. The licence, granted for its Brisbane-based biomedical facility, clears a critical regulatory hurdle and allows Vaxxas

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