• Sign In
  • Sign Out
  • My Account
Subscribe
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
  • Special reports
Clarivate
  • Data Snapshots
  • BioWorld
  • BioWorld MedTech
  • Infographics: Dynamic digital data analysis
  • Index insights
  • Special reports
  • Infographics: Dynamic digital data analysis
  • Trump administration impacts
  • 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.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • 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
Home » Topics » Regulatory » TGA

TGA
TGA RSS Feed RSS

Neurology/Psychiatric

Xgene gains Australian clearance for phase I study of XG-2002

March 14, 2024
Xgene Pharmaceutical Pty Ltd., a subsidiary of Xgene Pharmaceutical Co. Ltd., has received approval in Australia to initiate a phase I trial of the selective TRPM8 blocker XG-2002 (RQ-00434739).
Read More
Art concept for gene therapy research
Neurology/Psychiatric

Encoded Therapeutics’ gene therapy for SCN1A+ Dravet syndrome gets clinical green light in US and Australia

Feb. 6, 2024
Encoded Therapeutics Inc. is advancing its lead gene therapy candidate, ETX-101, for the treatment of SCN1A+ Dravet syndrome into the clinic.
Read More
Futuristic medicine research illustration with petri dishes and pipette
Infection

Asieris Pharmaceuticals obtains approval to conduct phase I study of antibacterial drug

Dec. 27, 2023
Asieris Pharmaceuticals Co. Ltd. announced that it has received approval to commence phase I clinical trials in Australia of its novel antibacterial drug, APL-2301 (ASN-1733, MET-102), under development for the treatment of Acinetobacter baumannii infections.
Read More
Endocrine/Metabolic

Iecure’s ECUR-506 cleared to enter clinic in Australia for OTC deficiency

Dec. 14, 2023
Iecure Inc. has received clearance from the Australian Therapeutic Goods Administration (TGA) of the company’s clinical trial notification (CTN) for ECUR-506 (formerly GTP-506), an investigational therapy in development for the treatment of ornithine transcarbamylase (OTC) deficiency in pediatric (or neonatal) patients.
Read More

Ausbiotech 2023: Big pharma sees promise in building mRNA platform in Australia to serve APAC

Nov. 7, 2023
By Tamra Sami
Multinational pharma companies like Moderna Inc. and Sanofi SA are setting up mRNA R&D centers in Australia and are banking on the country’s decades of mRNA expertise to bring new therapeutics to the clinic and to serve as regional hubs in Asia Pacific, speakers said during the Ausbiotech 2023 conference held Nov 1-3 in Brisbane, Australia.
Read More

Ausbiotech 2023: Big pharma sees promise in building mRNA platform in Australia to serve APAC

Nov. 6, 2023
By Tamra Sami
Multinational pharma companies like Moderna Inc. and Sanofi SA are setting up mRNA R&D centers in Australia and are banking on the country’s decades of mRNA expertise to bring new therapeutics to the clinic and to serve as regional hubs in Asia Pacific, speakers said during the Ausbiotech 2023 conference held Nov 1-3 in Brisbane, Australia.
Read More

TGA revisits framework for audits for devices entering Australian market

July 26, 2023
By Mark McCarty
Australia’s Therapeutic Goods Administration (TGA) has issued a regulatory proposal regarding the agency’s approach to audits for devices, a proposal that might reduce the number of these audits. TGA said it may limit audits to the highest-risk devices and may eliminate them for devices that have been granted market access in other regulatory jurisdictions.
Read More
Flag of Australia, sky background

TGA eyes revamp of regulations for devices with biological tissues

July 24, 2023
By Mark McCarty
Australia’s Therapeutic Goods Administration (TGA) is reconsidering its approach to regulating devices that bear materials of animal, microbial or recombinant origin, a broad class of products that includes transcatheter aortic valve replacement (TAVR) devices.
Read More

UK’s MHRA formally accepts extended timeline for acceptance of CE mark

July 3, 2023
By Mark McCarty
The difficulties in rolling out the EU’s Medical Device Regulation are well known, but the attendant delays continue to exert ripple effects in other markets. The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has formally extended the time frame for acceptance of existing CE marked devices into the U.K. market, another demonstration of the ongoing turmoil associated with the herky-jerky deployment of the MDR.
Read More

TGA eyes mutual recognition with EU for in vitro diagnostics

June 21, 2023
By Mark McCarty
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR.
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 July 9, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for July 9, 2025.
  • Illustration of the β2-adrenergic receptor

    Exercise-mimicking compound offers alternative to GLP-1 therapies

    BioWorld
    An experimental drug for treating diabetes and obesity has been shown to lower blood sugar levels and increase fat burning. It is a β2-adrenergic receptor (β2AR)...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for July 8, 2025
  • 3D rendering of a molecular glue mediating the interaction between two proteins

    With surface mimicry, molecular glues shed hairpin need

    BioWorld Science
    Degradation is a therapeutic strategy that could offer possibilities to get at currently undruggable target proteins. In targeted degradation, compounds induce...
  • 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
    • 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

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • 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