News

TGA SME Assist presents "Meeting your Obligations" a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation.

The TGA has provisionally approved a paediatric dose of the Moderna COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 months to less than 6 years.).

On 20 August 2021 the TGA granted provisional approval to GlaxoSmithKline Australia Pty Ltd in relation to sotrovimab (XEVUDY).

On 10 July 2020 the Therapeutic Goods Administration (TGA) granted provisional approval to remdesivir ("Veklury", Gilead Sciences Pty Ltd) as the first treatment option for COVID-19

Updated information

The TGA granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia.