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RSS FeedPosted by Michael Wonder on 21 Oct 2021
FDA takes additional actions on the use of a booster dose for COVID-19 vaccines
20 October 2021 - Today, the U.S. FDA took action to expand the use of a booster dose for COVID-19 vaccines ...
Posted by Michael Wonder on 21 Oct 2021
Delivery of Novavax vaccine may be delayed in Australia due to reported manufacturing issues
21 October 2021 - Australians may not get access to the Novavax vaccine this year with reports of manufacturing problems causing ...
Posted by Michael Wonder on 21 Oct 2021
COVID-19 vaccine weekly safety report (21 October 2021)
21 October 2021 - To 17 October 2021, approximately 32.7 million vaccine doses have been given in Australia – 18.3 million ...
Posted by Michael Wonder on 21 Oct 2021
FDA grants breakthrough device designation for Biological Dynamics’ early stage pancreatic cancer detection test
20 October 2021 - Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita ...
Posted by Michael Wonder on 20 Oct 2021
Stealth BioTherapeutics receives refusal to file letter from the FDA
20 October 2021 - Stealth BioTherapeutics today announced that it received a Refusal to File letter from the United States FDA ...
Posted by Michael Wonder on 20 Oct 2021
FDA expands approval of Dupixent (dupilumab) to include children aged 6 to 11 years with moderate to severe asthma
20 October 2021 - Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years ...
Posted by Michael Wonder on 20 Oct 2021
Luminopia announces FDA approval of digital therapeutic that uses TV shows to improve vision in children with lazy eye
20 October 2021 - Luminopia One improves vision in children with amblyopia, the leading cause of vision loss in children, and ...
Posted by Michael Wonder on 20 Oct 2021
TGA approves Brukinsa for another use
20 October 2021 - The second approval for zanubrutinib this month. ...
Posted by Michael Wonder on 20 Oct 2021
Chiesi Global Rare Diseases announces approval of Ferriprox (deferiprone) in Canada for the treatment of iron overload in sickle cell disease
15 October 2021 - Chiesi Global Rare Diseases announced today that Health Canada has approved Ferriprox (deferiprone) for the treatment of ...
Posted by Michael Wonder on 20 Oct 2021
FDA pre-submission for saliva based glucose test to replace invasive finger prick
19 October 2021 - The iQ Group Global, on behalf of its subsidiary, Life Science Biosensor Diagnostics, is pleased to announce ...
Posted by Michael Wonder on 19 Oct 2021
Akero Therapeutics receives FDA fast track designation for efruxifermin for the treatment of NASH
19 October 2021 - Akero Therapeutics today announced that the U.S. FDA has granted fast track designation to its lead program ...
Posted by Michael Wonder on 19 Oct 2021
Dr. Reddy's Laboratories announces approval for lenalidomide capsules from the U.S. FDA
19 October 2021 - Dr. Reddy’s Laboratories today announced the final approval of its abbreviated new drug application for lenalidomide 2.5 ...
Posted by Michael Wonder on 19 Oct 2021
New medicine for breast cancer approved by the TGA
19 October 2021 - Enhertu has been approved for provisional registration. ...
Posted by Michael Wonder on 19 Oct 2021
FDA to allow ‘mix and match’ approach for Covid booster shots
18 October 2021 - The agency may act this week, when it is expected to authorise booster shots for recipients of ...
Posted by Michael Wonder on 19 Oct 2021
Health Canada receives submission from Pfizer-BioNTech to authorise the use of Comirnaty COVID-19 vaccine in children 5 to 11 years of age
18 October 2021 - Today, Health Canada received a submission from Pfizer-BioNTech seeking an authorisation for the use of its Comirnaty ...