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RSS FeedPosted by Michael Wonder on 09 Dec 2021
FDA authorises new long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals
8 December 2021 - Today, the U.S. FDA issued an emergency use authorization for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and ...
Posted by Michael Wonder on 08 Dec 2021
FoundationOne CDx receives FDA approval as a companion diagnostic for BRAF inhibitor therapeutics in melanoma
8 December 2021 - Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved as ...
Posted by Michael Wonder on 08 Dec 2021
FDA takes new steps aimed at advancing development of individualised medicines to treat genetic diseases
7 December 2021 - Today, the FDA is issuing a draft guidance to provide recommendations for managing the administration of individualised ...
Posted by Michael Wonder on 08 Dec 2021
Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says
8 December 2021 - Pfizer CEO Albert Bourla said he’s confident the full results from the clinical trials will show that ...
Posted by Michael Wonder on 08 Dec 2021
TGA approves booster doses of the Moderna COVID-19 vaccine Spikevax
8 December 2021 - The TGA has provisionally approved a booster dose of the Moderna COVID-19 vaccine, SPIKEVAX, for individuals ...
Posted by Michael Wonder on 08 Dec 2021
Novavax COVID-19 vaccine could be approved very soon, says EMA chief
8 December 2021 - The head of the EMA on Tuesday said that it could soon approve the COVID-19 vaccine ...
Posted by Michael Wonder on 08 Dec 2021
Improvements to clinical trials will strengthen Australia’s economy and benefit patients
8 December 2021 - Clinical trials in Australia need improvements if we are to increase our global competitiveness says Medicines ...
Posted by Michael Wonder on 08 Dec 2021
New therapies for a range of conditions are coming in 2022
8 December 2021 - Haemophilia, brain disorders and malaria are being targeted. ...
Posted by Michael Wonder on 08 Dec 2021
Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics announce the initiation of rolling submission of a new drug application for CUTX-101, copper histidinate, for treatment of Menkes disease
7 December 2021 - Cyprium Therapeutics with support from its licensing partner Sentynl Therapeutics today announced the initiation of a ...
Posted by Michael Wonder on 08 Dec 2021
Saol Therapeutics announces FDA approval of Lyvispah (baclofen) oral granules
7 December 2021 - Saol Therapeutics today announced that the U.S. FDA has approved Saol's Lyvispah (baclofen) oral granules. ...
Posted by Michael Wonder on 07 Dec 2021
EMA and ECDC recommendations on heterologous vaccination courses against COVID-19
7 December 2021 - ‘Mix-and-match’ approach can be used for both initial courses and boosters. ...
Posted by Michael Wonder on 07 Dec 2021
Daré announces FDA approval of Xaciato (clindamycin phosphate) vaginal gel as a treatment for bacterial vaginosis
7 December 2021 - Prescribing information supports positioning of Xaciato as a first line option for the treatment of bacterial ...
Posted by Michael Wonder on 07 Dec 2021
FDA approves Octapharma’s Cutaquig 16.5% for paediatric PI patients, providing flexible treatment options
7 December 2021 - Families, providers can utilise flexible infusion schedule to meet patient needs. ...
Posted by Michael Wonder on 07 Dec 2021
Linus Biotechnology receives FDA breakthrough device designation for StrandDx-ASD exposome sequencing diagnostic
7 December 2021 - Linus Biotechnology today announced that the U.S. Food and Drug Administration Center for Devices and Radiological Health ...
Posted by Michael Wonder on 07 Dec 2021
U.S. plans to fast track revamped COVID-19 vaccines
5 December 2021 - Study from South Africa suggests the fast-spreading Omicron variant might cause less severe illness than its predecessors. ...