BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Wednesday, December 17, 2025
Home » Topics » Regulatory » TGA

TGA
TGA RSS Feed RSS

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
Spectral AI Deepview system

Spectral AI collaborates with Polynovo to test wound healing device

July 12, 2024
By Tamra Sami
AI-focused medical diagnostics company Spectral AI Inc. is collaborating with burn wound therapy company Polynovo Ltd. to test limited deployment of Spectral’s Deepview system for predicting burn healing in Australia.
Read More
Pill in immersive interface
Neurology/psychiatric

Satellos files in Australia to begin clinical testing of SAT-3247 for Duchenne muscular dystrophy

July 12, 2024
Satellos Bioscience Inc. has submitted a clinical research proposal to a Human Research Ethics Committee (HREC) in Australia seeking regulatory authorization under the Therapeutic Goods Administration (TGA)’s clinical trial notification scheme to conduct a first-in-human phase I trial of SAT-3247.
Read More
DNA in drug capsules
Immuno-oncology

Interius’ INT-2104 receives Australian clearances for clinical trial in B-cell malignancies

July 9, 2024
Interius Biotherapeutics Inc. has been granted Human Research Ethics Committee (HREC) approval and clinical trial notification clearance by Australia’s Therapeutic Goods Administration (TGA) to begin a first-in-human trial of INT-2104, its lead in vivo CAR candidate for treatment of B-cell malignancies.
Read More
Flag of Australia, sky background

Australia poised to harness the power of radiopharmaceuticals

May 7, 2024
By Tamra Sami
Australia is poised to play a leading role in the rise of the global radiopharmaceutical industry, as advanced therapies drive significant investment and rapid expansion, according to a new discussion paper from industry accelerator Mtpconnect.
Read More
Coin inserted into Australian map

Australia investing AU$1.89B for new research, clinical trials

May 7, 2024
By Tamra Sami
The Australian government is investing AU$1.89 billion (US$1.25 billion) in what it is calling a “once-in-a generation transformation” of health and medical research in Australia with $1.4 billion tagged for new research for the Medical Research Future Fund.
Read More
Regulatory icons

Mexico’s COFEPRIS adds SaMD to definitions in revised labeling rule

May 7, 2024
By Mark McCarty
Mexico’s Federal Commission for Protection Against Sanitary Risk (COFEPRIS) has released a draft proposal that would overhaul the 2008 version of the rule for device labeling, a document that includes several key proposed reforms.
Read More
Coin inserted into Australian map

Australia investing AU$1.89B for new research, clinical trials

May 6, 2024
By Tamra Sami
The Australian government is investing AU$1.89 billion (US$1.25 billion) in what it is calling a “once-in-a generation transformation” of health and medical research in Australia with $1.4 billion tagged for new research for the Medical Research Future Fund.
Read More
Flag of Australia, sky background

Australia poised to harness the power of radiopharmaceuticals

May 3, 2024
By Tamra Sami
Australia is poised to play a leading role in the rise of the global radiopharmaceutical industry, as advanced therapies drive significant investment and rapid expansion, according to a new discussion paper from industry accelerator Mtpconnect.
Read More
Previous 1 2 3 4 5 6 7 8 9 … 16 17 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Dec. 17, 2025.
  • IPO puzzle pieces

    Medline raises $6.3B in fourth med-tech IPO of December

    BioWorld MedTech
    Medline Inc. returned to the public markets with a blockbuster IPO of $6.26 billion, reportedly this year’s largest IPO globally. The upsized offering of more...
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Dec. 17, 2025.
  • Child pushing away bowl of peanuts

    Vitesse finesse pays off: DBV wins in peanut allergy phase III

    BioWorld

    DBV Technologies SA’s pivotal phase III trial with the Viaskin Peanut allergy patch came through for the company, and officials plan a BLA filing with the U.S....

  • IPO stock market ticker

    Acryl raises $28M IPO, aiming to bridge medical divide with AI

    BioWorld MedTech
    Acryl Inc. debuted on South Korea’s Kosdaq Dec. 16, raising ₩42.12 billion ($28.5 million) in an IPO. Shares (KOSDAQ:0007C0) closed at ₩67,000 on the first day,...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • NME Digest
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing