Sep 8, 2021 | News, Regulatory
American biotech company Novavax announced that it will begin an early-staged trial for a combined influenza/COVID-19 vaccine. The trial will be conducted in Australia and will include 640 adults (between 50 and 70 years of age) and who have either been previously...
Apr 23, 2021 | News, Regulatory
The Therapeutic Goods Administration (TGA) has approved the use of Global Sarcoma Therapy called YONDELISÒ, marketed by Specialised Therapeutics, for Australian patients afflicted with “unresectable or metastatic liposarcoma or leiomyosarcoma who received a...
Jan 26, 2021 | News, Regulatory
Yesterday (1/25), Australia’s Therapeutic Good Administration (TGA) authorized Pfizer and BioNTech’s COVID-19 vaccine. The provisional approval is the first for COVID-19 vaccines in Australia’s market for individuals 16 years and older and is expected to be...
Jan 21, 2021 | News, Regulatory
Yesterday (1/20), Novavax received provisional determination from Australia’s Therapeutic Goods Administration for its COVID-19 vaccine, marking the first steps in gaining provisional approval. Australia’s provisional approval pathway allows for drug therapies (or...
