Prescription medicines: applications under evaluation

24 August 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...

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Aussies could get omicron targeted jab earlier than most

18 July 2022 - Australia could become one of the first countries in the world to administer an omicron-specific vaccine, ...

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Report on 'Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives' - TGA response

4 July 2022 - n November 2021 the TGA commissioned MTP Connect to conduct a stakeholder review of the regulatory ...

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Fees and charges: summary from 1 July 2022

27 June 2022 - The TGA has updated its summary of fees and charges effective 1 July 2022. ...

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Prescription medicines: applications under evaluation (May 2022)

26 May 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...

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Pfizer settles two lawsuits, starts another over etanercept biosimilar in Australia

17 May 2022 - After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit ...

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TGA removes age limit for BBIBP-CorV (Sinopharm) COVID-19 vaccine recognition for international travel to Australia

13 May 2022 - The TGA has determined that the BBIBP-CorV (Sinopharm) COVID-19 vaccine will be 'recognised' for all ages for ...

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iHealthScreen announces TGA approval for iPredict automated AI system for early diagnosis of diabetic retinopathy, age-related macular degeneration and glaucoma suspect

19 April 2022 - iHealthScreen is the first company in the USA to receive a CE certification, Australian Health approval, and ...

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Drug trials a ‘ticking time bomb’: ex-TGA agent

28 March 2022 - A former TGA official who led the regulator’s inspections program has warned that a lack of ...

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2022 seasonal influenza vaccines

25 March 2022 - The Australian Influenza Vaccine Committee has reviewed data related to epidemiology, antigenic and genetic characteristics of recent ...

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Australian COVID nasal spray not on shop shelves amid TGA dispute

4 March 2022 - Melbourne start-up Starpharma is at loggerheads with the medicines regulator over the approvals process for its ...

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‘Grumpy’ TGA boss unloads over people downplaying COVID’s effect on kids

23 February 2022 - The head of Australia’s medicines regulator has unloaded on those downplaying the effect COVID-19 has on ...

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Controversial Alzheimer’s drug under TGA review ‘should not be approved’

21 February 2022 - Patients will be put at risk and taxpayers will face a significant economic burden if aducanumab receives ...

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Patent box legislation to promote Australian innovation

11 February 2022 - Medicines Australia notes the introduction of patent box legislation, Treasury Laws Amendment (Tax Concession for Australian ...

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To hell and back: devices meant to ease pain are causing trauma

5 February 2022 - A $35,000 treatment at the forefront of medical technology which pumps electric pulses into the spine ...

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