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BioWorld - Tuesday, April 7, 2026
Home » Topics » Regulatory » TGA

TGA
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Melanoma cells stained with an H & E stain and magnified to 320x.

AI Medi Scan develops at-home melanoma detection app

Sep. 19, 2024
By Tamra Sami
Australia is the skin cancer capital of the world, but with a shortage of dermatologists, patients often wait too long to get skin checks that could end up costing them their lives.
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Australia flag with microscope, test tubes

Australia’s HTA consultation wraps up with 50 recommendations

Sep. 18, 2024
By Tamra Sami
Australia’s Health Department has released the final report of the Health Technology Assessment (HTA) Review that makes 50 recommendations for improving access to new health technologies while tackling inequity, simplifying HTA processes and making it easier for consumers and clinicians to participate.
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Australia’s HTA consultation wraps up with 50 recommendations

Sep. 17, 2024
By Tamra Sami
Australia’s Health Department has released the final report of the Health Technology Assessment (HTA) Review that makes 50 recommendations for improving access to new health technologies while tackling inequity, simplifying HTA processes and making it easier for consumers and clinicians to participate.
Read More
Woman holding neck in pain

Good Tryp: Psilocybin trial brings pain relief for fibromyalgia

Aug. 27, 2024
By Tamra Sami
All patients dosed in a phase IIa trial with Tryptamine Therapeutics Ltd.’s (Tryp) oral psilocybin (TRP-8802) trial reported an improvement in fibromyalgia pain severity, sleep, and pain interference.
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Woman holding neck in pain

Good Tryp: Psilocybin trial brings pain relief for fibromyalgia

Aug. 26, 2024
By Tamra Sami
All patients dosed in a phase IIa trial with Tryptamine Therapeutics Ltd.’s (Tryp) oral psilocybin (TRP-8802) trial reported an improvement in fibromyalgia pain severity, sleep, and pain interference.
Read More
Flag of Australia, sky background

TGA wigs out over assistive tech in new regulatory consultation

Aug. 23, 2024
By Mark McCarty
TGA opened a consultation for regulation of assistive technologies, a key element of which is to make determinations about the regulatory status of some of these products. While the agency makes clear that some items that are currently unregulated may soon be subject to regulation, one of the more innocuous-seeming articles that may fall under regulation is the common and seemingly innocuous wig.
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Wegovy available in Australia; hefty price likely to deter use

Aug. 20, 2024
By Tamra Sami
In the wake of shortages for Novo Nordisk A/S’ Ozempic (semaglutide), Australia’s Therapeutic Goods Administration has announced that Wegovy, which has the same active ingredient, is now available in Australia and is advising prescribers to stop prescribing Ozempic off-label for weight loss.
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Test tubes, dropper and capsules
Inflammatory

Immunesensor Therapeutics’ cGAS inhibitor to enter clinic in Australia

Aug. 19, 2024
Immunesensor Therapeutics Inc. has received Human Research Ethics Committee (HREC) approval and clinical trial notification (CTN) clearance by Australia’s Therapeutic Goods Administration (TGA) to initiate a phase I study of IMSB-301, a novel, orally available small-molecule cGAS inhibitor that is being developed for the treatment of inflammatory and autoimmune diseases.
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Wegovy available in Australia; hefty price likely to deter use

Aug. 15, 2024
By Tamra Sami
In the wake of shortages for Novo Nordisk A/S’ Ozempic (semaglutide), Australia’s Therapeutic Goods Administration has announced that Wegovy, which has the same active ingredient, is now available in Australia and is advising prescribers to stop prescribing Ozempic off-label for weight loss.
Read More
Eye and DNA illustration
Ocular

Rznomics gains Australian clearance to advance RZ-004 into clinic for retinitis pigmentosa

July 15, 2024
Rznomics Inc. has received clinical trial notification (CTN) from Australia’s Therapeutic Goods Administration (TGA) for the initiation of a phase I/IIa trial evaluating RZ-004, a gene therapeutic candidate for autosomal dominant retinitis pigmentosa with rhodopsin mutation.
Read More
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