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Results For "Therapeutic-Goods-Administration"

12 News Found

Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ
Drug Approval | December 17, 2024

Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ

The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market


Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr
News | August 10, 2024

Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr

This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.


Sun Pharmaceuticals receives approval for Winlevi in Australia
Drug Approval | March 19, 2024

Sun Pharmaceuticals receives approval for Winlevi in Australia

Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older


Lupin receives approval from TGA Australia for Tiotropium Dry Powder
Drug Approval | July 26, 2023

Lupin receives approval from TGA Australia for Tiotropium Dry Powder

Tiotropium (as bromide monohydrate) 18 micrograms powder for inhalation in capsule


Moderna announces regulatory submissions for its RSV vaccine
News | July 10, 2023

Moderna announces regulatory submissions for its RSV vaccine

The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia


Inmagene receives USFDA's IND clearance for ox40 antagonist
Biotech | May 01, 2022

Inmagene receives USFDA's IND clearance for ox40 antagonist

The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients


New very-high-sensitivity rapid antigen test kits hit Australian market
News | April 11, 2022

New very-high-sensitivity rapid antigen test kits hit Australian market

New Covid-19 Medriva Rapid Antigen Test kits with very high- sensitivity now available in Australia


Health Canada authorizes Moderna's COVID-19 vaccine in children (6-11 Years)
News | March 18, 2022

Health Canada authorizes Moderna's COVID-19 vaccine in children (6-11 Years)

The announcement follows recent authorization of the Company's mRNA COVID-19 vaccine in Australia and the European Union for children aged 6-11 years


Moderna’s Covid-19 vaccine approved in Australia for children (6-11 years)
News | February 17, 2022

Moderna’s Covid-19 vaccine approved in Australia for children (6-11 years)

Moderna's vaccine has already received regulatory approval for adults and adolescents in Australia


Pfizer and OPKO update on the Biologics License Application for Somatrogon
Biotech | January 22, 2022

Pfizer and OPKO update on the Biologics License Application for Somatrogon

Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward