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RSS FeedPosted by Michael Wonder on 28 Jan 2021
Advocacy groups urge Biden administration not to tap Woodcock as FDA commissioner
27 January 2021 - As the Biden White House attempts to fashion its health policies, a coalition of consumer and ...
Posted by Michael Wonder on 28 Jan 2021
Clarification of Comirnaty dosage interval
28 January 2021 - EMA’s human medicines committee (CHMP) has updated the product information for the COVID-19 vaccine Comirnaty to ...
Posted by Michael Wonder on 28 Jan 2021
TGA to rule on psychedelic drug access for mental health problems
28 January 2021 - A group of prominent Australians is continuing to push for greater access to psychedelic drugs to ...
Posted by Michael Wonder on 27 Jan 2021
E.U. and U.K. fighting over scarce vaccines
27 January 2021 - As vaccine production falls behind schedule, and the European Union lags in inoculating people, Brussels and London ...
Posted by Michael Wonder on 27 Jan 2021
EU demands UK made AstraZeneca vaccine doses
27 January 2021 - The EU has urged pharmaceutical firm AstraZeneca to supply it with more doses of its COVID-19 ...
Posted by Michael Wonder on 27 Jan 2021
European Medicines Agency accepts GBT’s marketing authorisation application for Oxbryta (voxelotor) for the treatment of haemolytic anemia in sickle cell disease
27 January 2021 - Global Blood Therapeutics today announced that the EMA has completed the validation of GBT’s marketing authorisation application ...
Posted by Michael Wonder on 27 Jan 2021
Australia’s COVID-19 vaccine information campaign begins
27 January 2021 - The Australian Government’s $23.9 million public information campaign to encourage Australians to get a COVID-19 vaccine begins ...
Posted by Michael Wonder on 27 Jan 2021
European Commission approves Keytruda (pembrolizumab) as first-line treatment in adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
26 January 2021 - Keytruda is first checkpoint inhibitor approved in Europe to treat MSI-H or dMMR colorectal cancer. ...
Posted by Michael Wonder on 27 Jan 2021
Alleviant Medical receives breakthrough device designation from FDA for transcatheter technology
25 January 2021 - Alleviant Medical today announced that the US FDA has granted the company a breakthrough device designation ...
Posted by Michael Wonder on 27 Jan 2021
PEDRA Technology receives FDA breakthrough device designation for its PEDRA Xauron real-time tissue perfusion system
25 January 2021 - Novel perfusion monitor achieves FDA breakthrough device Designation for real-time, peri-procedural monitoring of tissue perfusion in patients ...
Posted by Michael Wonder on 26 Jan 2021
Scott Morrison says Australia will not be a hostage to global vaccine shortages
26 January 2021 - Scott Morrison has revealed why Australia won’t be “completely hostage” to overseas vaccine schedules and shortages. ...
Posted by Michael Wonder on 26 Jan 2021
MeiraGTx announces AAV-CNGA3 granted fast track designation by U.S. FDA for treatment of achromatopsia
26 January 2021 - MeiraGTx today announced that the U.S. FDA has granted fast track designation to its AAV-CNGA3 gene therapy ...
Posted by Michael Wonder on 26 Jan 2021
Recordati Rare Diseases: Carbaglu (carglumic acid) receives U.S. FDA approval for a new indication to treat acute hyperammonaemia associated with propionic acidemia and methylmalonic acidemia
26 January 2021 - Carbaglu is first and only FDA approved medication for hyperammonaemia associated with these rare conditions. ...
Posted by Michael Wonder on 26 Jan 2021
Vertex announces U.S. FDA acceptance of supplemental new drug application for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations
26 January 2021 - FDA grants priority review of the application and sets a PDUFA target action date of 8 June ...
Posted by Michael Wonder on 26 Jan 2021
FDA approves Theranica's Nerivio for acute treatment of migraine in adolescents
25 January 2021 - Theranica today announced that its Nerivio therapeutic device has received the FDA clearance to market for ...