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BioWorld - Sunday, January 25, 2026
Home » Topics » Regulatory » TGA

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DermR collection device

Skin cancer study: Dermr patch as effective as skin biopsy

Dec. 20, 2024
By Tamra Sami
A new method to diagnose skin cancer was validated for the first time in clinical trials that show Dermr Health Solutions Pty Ltd.’s non-invasive microneedle patch collects near-equivalent genetic information compared to a skin biopsy without pain or cutting.
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Australia reimburses Vazkepa a decade after US approval

Nov. 5, 2024
By Tamra Sami
For the first time, Australians have access to CSL Inc.’s Vazkepa (icosapent ethyl/Vascepa) for managing cardiovascular disease more than a decade after the drug was first approved in the U.S.
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Australia reimburses Vazkepa a decade after US approval

Nov. 4, 2024
By Tamra Sami
For the first time, Australians have access to CSL Inc.’s Vazkepa (icosapent ethyl/Vascepa) for managing cardiovascular disease more than a decade after the drug was first approved in the U.S.
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3D map of China

China’s NMPA finalizes rule for novel device classification

Oct. 3, 2024
By Mark McCarty
China’s National Medical Products Administration wrapped up a revision of its device classification procedures, providing entries into one of the world’s largest markets a mechanism for obtaining means for determining the risk of a novel device type.
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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. 24, 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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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.
Read More
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
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