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RSS FeedPosted 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 ...
Posted by Michael Wonder on 18 Oct 2021
Avadel Pharmaceuticals announces ongoing FDA review of NDA for FT218 for patients with narcolepsy
15 October 2021 - Avadel Pharmaceuticals announced today that the U.S. FDA notified the company that the review of the new ...
Posted by Michael Wonder on 18 Oct 2021
On COVID-19 booster shots, the FDA has overstepped its role
18 October 2021 - Booster shots for all adults six months after being vaccinated against COVID-19 are safe, effective, and ...
Posted by Michael Wonder on 18 Oct 2021
US FDA approves expanded indication of Gilead’s Biktarvy for treatment of HIV-1 in paediatric populations
18 October 2021 - FDA approves low dose tablet for HIV treatment in virologically suppressed children weighing at least 14 kg. ...
Posted by Michael Wonder on 18 Oct 2021
United Therapeutics provides an update on the progress of the Tyvaso DPI new drug application
18 October 2021 - Draft label contains both PAH and PH-ILD indications; no contra-indications and no boxed warning. ...