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BioWorld - Sunday, December 21, 2025
Home » Topics » Regulatory » TGA

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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.
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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.
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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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