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 09 Aug 2021
Quality assurance requirements of the G-BA also apply to new CAR-T cell therapy
5 August 2021 - The Federal Joint Committee (G-BA) today evaluated the new cancer drug with the trade name Tecartus and ...
Posted by Michael Wonder on 09 Aug 2021
COVID-19 vaccine: international collaboration
6 August 2021 - The Therapeutic Goods Administration has strong working relationships with a wide range of international agencies and ...
Posted by Michael Wonder on 08 Aug 2021
Biden yet to nominate new FDA chief even as delta surges
8 August 2021 - President Biden has yet to nominate a permanent head of the FDA at a time when ...
Posted by Michael Wonder on 08 Aug 2021
US tropical disease priority review vouchers: lessons in promoting drug development and access
6 August 2021 - The COVID-19 global pandemic has devastated lives and economies. It has served as a reminder of how ...
Posted by Michael Wonder on 08 Aug 2021
New contraceptive pill: ‘safer’ Slinda pill with no blood clot risk, no periods available in Australia
8 August 2021 - A new generation contraceptive pill with no blood clot risks, that can be used by almost all ...
Posted by Michael Wonder on 08 Aug 2021
Additional COVID-19 treatment for Australia
8 August 2021 - The Australian Government has secured an initial shipment of over 7,700 doses of the novel monoclonal ...
Posted by Michael Wonder on 08 Aug 2021
Moderna vaccine set to be available in Australia by September
8 August 2021 - Australians will have a third vaccine option within weeks, with the country’s drug regulator set to ...
Posted by Michael Wonder on 08 Aug 2021
Novavax booster doses to soon join stockpile
6 August 2021 - Novavax will apply for approval for its COVID-19 vaccine in Australia “within weeks” of making a ...
Posted by Michael Wonder on 06 Aug 2021
Actuate Therapeutics announces FDA fast track designation for 9-ING-41 for treatment of pancreatic cancer
5 August 2021 - Actuate Therapeutics today announced that the U.S. FDA has granted fast track designation for 9-ING-41 for treatment ...
Posted by Michael Wonder on 06 Aug 2021
FDA approves new treatment for Pompe disease
6 August 2021 - Today, the U.S. FDA approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of ...
Posted by Michael Wonder on 06 Aug 2021
Novavax and European Commission finalise advance purchase agreement for up to 200 million doses of COVID-19 vaccine
4 August 2021 - Agreement for 100 million doses with option for additional 100 million doses through 2023. ...
Posted by Michael Wonder on 06 Aug 2021
Spectrum Pharmaceuticals receives complete response letter from FDA for Rolontis (eflapegrastim)
6 August 2021 - Spectrum Pharmaceuticals today announced receipt of a complete response letter from the U.S. FDA regarding the company’s ...
Posted by Michael Wonder on 06 Aug 2021
Merck’s Keytruda (pembrolizumab) significantly prolonged recurrence-free survival compared to placebo as adjuvant therapy for patients with stage II resected high-risk melanoma in Phase 3 KEYNOTE-716 trial
5 August 2021 - US FDA grants priority review to Merck’s application for Keytruda based on these data. ...
Posted by Michael Wonder on 06 Aug 2021
Novavax delays Covid vaccine emergency authorisation submission to FDA until fourth quarter
5 August 2021 - The company says it is still on track to produce 100 million doses per month by the ...
Posted by Michael Wonder on 06 Aug 2021
Interoperability of track and trace systems: key to public health protection
6 August 2021 - EMA has endorsed recommendations developed by the International Coalition of Medicines Regulatory Authorities to facilitate the use ...