Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 20 Jan 2022
COVID-19 vaccine weekly safety report (20 January 2022)
20 January 2022 - To 16 January 2022, the TGA has received 428 reports which have been assessed as likely to ...
Posted by Michael Wonder on 20 Jan 2022
NICE moves: increased accessibility and flexibility for health tech
19 January 2022 - NICE also aims to make strides in digital, genomic and antimicrobial technologies ...
Posted by Michael Wonder on 20 Jan 2022
NICE signals commitment to greater flexibility in its evaluation of promising new health technologies and making patient access fairer
20 January 2022 - Changes to the way medicines and other health technologies are evaluated by NICE for use in the ...
Posted by Michael Wonder on 20 Jan 2022
Statement on the arrival of the Novavax vaccine and COVID-19 pills
20 January 2022 - Medicines Australia welcomes the TGA’s provisional approval for the Novavax COVID-19 vaccine and the provisional approval ...
Posted by Michael Wonder on 20 Jan 2022
Omeros confirms submission of response to FDA regarding the BLA for narsoplimab in the treatment of HSCT-TMA
19 January 2022 - Omeros Corporation today confirmed that earlier this month the company submitted to the U.S. FDA its response ...
Posted by Michael Wonder on 20 Jan 2022
Pathogenomix granted FDA breakthrough device designation
19 January 2022 - Patho-Seq uses next generation sequencing to rapidly identify bacteria from human samples during dangerous and life-threatening ...
Posted by Michael Wonder on 20 Jan 2022
Two anti-viral COVID-19 treatments approved
20 January 2022 - The Australian Government welcomes the Therapeutic Goods Administration’s provisional approval of the first oral treatments for COVID-19 ...
Posted by Michael Wonder on 20 Jan 2022
ChemoCentryx announces EU approval of Tavneos (avacopan) for the treatment of ANCA associated vasculitis
19 January 2022 - ChemoCentryx today announced that Tavneos (avacopan) has been approved within the European Union in combination with a ...
Posted by Michael Wonder on 20 Jan 2022
Celcuity receives FDA fast track designation for gedatolisib in HR positive, HER2 negative metastatic breast cancer
18 January 2022 - On track to finalise Phase 3 clinical trial design for gedatolisib with FDA feedback in first quarter. ...
Posted by Michael Wonder on 20 Jan 2022
TGA provisionally approves Novavax (Biocelect) COVID-19 vaccine Nuvaxovid
20 January 2022 - The Therapeutic Goods Administration has granted provisional approval to Biocelect (on behalf of Novavax) for its ...
Posted by Michael Wonder on 19 Jan 2022
Beyond survival: the US FDA confirms surrogate end points for patients with newly diagnosed acute myeloid leukaemia treated with intensive chemotherapy
10 January 2022 - The treatment of acute myeloid leukaemia has rapidly evolved over the past decade. ...
Posted by Michael Wonder on 19 Jan 2022
TGA provisionally approves two oral COVID-19 treatments, molnupiravir (Lagevrio) and nirmatrelvir and ritonavir (Paxlovid)
20 January 2022 - The TGA has granted provisional approval to two oral COVID-19 treatments: Paxlovid (nirmatrelvir and ritonavir, Pfizer) ...
Posted by Michael Wonder on 19 Jan 2022
Lieutenant General John Frewen says he expects TGA approval of Novavax vaccine is 'imminent'
19 January 2022 - The head of Australia's vaccine rollout expects one to two per cent of Australians who remain unvaccinated ...
Posted by Michael Wonder on 19 Jan 2022
Sensydia receives FDA breakthrough device designation for CPS non-invasive cardiac monitoring device
19 January 2022 - Sensydia today announced that its cardiac performance system has been granted breakthrough device designation by the United ...
Posted by Michael Wonder on 19 Jan 2022
UK’s NICE to launch sweeping changes to drug assessments to be faster, more agile
19 January 2022 - The health technology assessment body has been under pressure from drugmakers and patient groups for years to ...