Blog
RSS FeedPosted by Michael Wonder on 09 Aug 2021
Daré Bioscience announces FDA acceptance and priority review of new drug application for DARE-BV1 for the treatment of bacterial vaginosis
9 August 2021 - New drug application supported by positive data from the DARE-BVFREE Phase 3 study, which demonstrated clinical cure ...
Posted by Michael Wonder on 09 Aug 2021
Skyrizi (risankizumab-rzaa) now available in the U.S. as a single 150 mg injection for adults with moderate to severe plaque psoriasis
9 August 2021 - Skyrizi is now the only four-dose-a-year biologic for psoriasis with options to administer via a single-dose pen ...
Posted by Michael Wonder on 09 Aug 2021
Calliditas receives FDA fast track designation for setanaxib in PBC
9 August 2021 - Calliditas Therapeutics today announced that the U.S. FDA has granted fast track designation for its lead NOX ...
Posted by Michael Wonder on 09 Aug 2021
TGA provisionally approves Moderna’s COVID-19 vaccine
9 August 2021 - Today, the Therapeutic Goods Administration, granted provisional approval to Moderna Australia for its COVID-19 vaccine—Spikevax (elasomeran)—making ...
Posted by Michael Wonder on 09 Aug 2021
Forxiga approved in the EU for the treatment of chronic kidney disease in patients with and without type 2 diabetes mellitus
9 August 2021 - Approval based on unprecedented DAPA-CKD Phase 3 data is the most significant advancement in chronic kidney ...
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. ...