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 Oct 2022
Department of Health tweaks the agenda for November 2022 PBAC meeting
19 October 2022 - Two minor changes made the day after the release of version 3. ...
Posted by Michael Wonder on 20 Oct 2022
COVID-19 vaccine safety report (20 October 2022)
20 October 2022 - To 16 October 2022, the TGA has received 705 reports which have been assessed as likely to ...
Posted by Michael Wonder on 20 Oct 2022
New Zealand, it's time to put Fairness in Focus
20 October 2022 - Medicines New Zealand is today relaunching their digital public awareness platform Fairness in Focus. ...
Posted by Michael Wonder on 20 Oct 2022
What the Makena vote means about accelerated approval, trust, and the FDA
19 October 2022 - On Wednesday, the FDA advisory committee that oversees obstetrics, reproductive, and urologic drugs voted 14-1 that ...
Posted by Michael Wonder on 20 Oct 2022
Ireland’s cancer survival rates lag behind other EU countries with access to new drugs ‘limited’
20 October 2022 - Patient access to newer cancer medicines is limited and comes later in Ireland compared to other ...
Posted by Michael Wonder on 20 Oct 2022
US FDA grants emergency use authorisation for Novavax COVID-19 Vaccine, adjuvanted as a booster for adults
19 October 2022 - Novavax today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorisation from the ...
Posted by Michael Wonder on 20 Oct 2022
How digital health innovators can successfully navigate evolving FDA regulations
19 October 2022 - In the rapidly changing landscape of digital health, innovation has often outpaced regulations, especially for novel ...
Posted by Michael Wonder on 20 Oct 2022
Sinaptica Therapeutics announces FDA breakthrough device designation for its novel non-invasive neurostimulation treatment for Alzheimer’s disease
19 October 2022 - Breakthrough designation is based on positive outcomes from a Phase 2 clinical trial in mild to ...
Posted by Michael Wonder on 20 Oct 2022
TGA provisionally approves Moderna’s COVID-19 vaccine for use as a booster dose in individuals 12 years and older
20 October 2022 - On 19 October 2022, the TGA provisionally approved Moderna's COVID-19 vaccine, Spikevax (elasomeran), for use as ...
Posted by Michael Wonder on 19 Oct 2022
MSAC publishes outcome for Mackenzie's mission
19 October 2022 - Mackenzie’s Mission is a research study providing reproductive genetic carrier screening to up to 10,000 couples across ...
Posted by Michael Wonder on 19 Oct 2022
Fostamatinib disodium hexahydrate for the treatment of patients with refractory chronic immune thrombocytopenia
19 October 2022 - NICE has published evidence-based recommendations on the use of fostamatinib disodium hexahydrate for the treatment of ...
Posted by Michael Wonder on 19 Oct 2022
EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
19 October 2022 - The EMA’s CHMP has recommended extending the use of Comirnaty and Spikevax targeting the original strain ...
Posted by Michael Wonder on 19 Oct 2022
Advancing real world evidence program
19 October 2022 - As announced in the Federal Register notice published on 20 October 2022, the FDA is conducting an ...
Posted by Michael Wonder on 19 Oct 2022
Zanubrutinib for the treatment of patients with Waldenström’s macroglobulinaemia
19 October 2022 - NICE has published evidence-based recommendations on the use of zanubrutinib for the treatment of adults with ...
Posted by Michael Wonder on 19 Oct 2022
EMA recommends approval of second adapted Spikevax vaccine
19 October 2022 - The EMA’s CHMP has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 ...