Latest Therapeutic Goods Administration News | Page 8

Australia’s first bivalent Covid vaccine to join rollout
Women’s Health Week: Breaking down barriers to abortion access in Australia
Imfinzi plus chemotherapy approved in US as first immunotherapy regimen for patients with advanced biliary tract cancer
ATAGI update following weekly Covid meeting 2 September
Study to investigate public perceptions of cannabidiol use
First Omicron-adapted Covid boosters are coming
New study to find COVID-fighting properties in existing medications
TGA provisionally approves Moderna bivalent Covid vaccine for use as booster dose in adults
ATAGI update following weekly Covid meeting 26 August
Novavax vaccine for adolescents aged 12
Proposed regulatory changes for clinical trials of medical devices
Shortage of tenecteplase 25 August
Positions vacant on key TGA statutory advisory committees
Doughbot Enterprises and Officer fined $87,312 and company and its Director undertake to comply with advertising rules for nicotine
TGA participates in global operation tackling illicit and counterfeit therapeutic goods
TGA grants provisional determination for sabizabulin for treatment of Covid
NetOptAwario’s new technology transforms detection of heart arrhythmias with AI and remote monitoring
WA individual fined $2,664 for alleged unlawful importation of nicotine vaping products
Hope for ‘inoperable’ cancer patients
CSIRO opens ‘missing link’ lab to developing Australian vaccine pipeline
Enviro Tech Holdings and company officers ordered by Federal Court to pay $96,000 for unlawful importation of surgical face masks
2San Pty Ltd fined $66,600 for allegedly failing to provide ongoing evidence to support performance of its Covid rapid antigen tests
Enhertu approved in US as first HER2-directed therapy for patients with HER2-low metastatic breast cancer
ATAGI update following weekly Covid meeting 4 August
Who is at fault when medical software gets it wrong?
How do epidurals work? And why is there a global shortage of them?
ATAGI recommendations on Covid vaccine use in children aged 6 months
TGA commences evaluation of Pfizer’s Covid vaccine for children aged 6 months to less than 5 years
NSW individual fined $2,664 for alleged unlawful advertising of nicotine vaping products
Phenix Health Pty Ltd directed to cease alleged unlawful advertising of nicotine vaping products
Advice on use of nirmatrelvir + ritonavir post labelled expiry date
What allegations of Alzheimer’s research fraud mean for patients
New pancreatic cancer treatment available
ATAGI update following weekly Covid meeting 29 July
Rapid Antigen Test cancellations not due to failure to detect Covid Omicron variant
Strapit Medical and Sports Supplies Pty Ltd undertakes to comply with advertising rules for therapeutic goods
Court proceedings initiated against Vapor Kings Pty Ltd and its director for alleged unlawful advertising of nicotine vaping
TGA provisionally approves Biocelect Pty Ltd Covid vaccine, NUVAXOVID, for use in individuals aged 12
13 Vape Pty Ltd directed to cease alleged unlawful advertising of nicotine vaping products
International consultation on medical device cybersecurity
ATAGI update following weekly Covid meeting 21 July
Person fined $31,698 for alleged unlawful advertising of disposable nicotine vaping products
TGA decision on children’s vaccination welcomed, but national uniformity needed
GP knowledge gaps regarding Zostavax use in immunocompromised people remain concerning, study finds
TGA provisionally approves Moderna Covid vaccine for use in children from 6 months
Shortage of tocilizumab medicines: Resolved
Shortage of tenecteplase
First-generation antihistamines – winter warning