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RSS FeedPosted by Michael Wonder on 18 Mar 2021
AstraZeneca ChAdOx1-S COVID-19
18 March 2021 - The TGA is closely reviewing reports of anaphylaxis after four cases were reported following the AstraZeneca ChAdOx1-S ...
Posted by Michael Wonder on 17 Mar 2021
FDA permits marketing of first SARS-CoV-2 diagnostic test using traditional premarket review process
17 March 2021 - BioFire Respiratory Panel 2.1 is the first COVID-19 diagnostic test granted marketing authorisation using the de novo ...
Posted by Michael Wonder on 17 Mar 2021
Sagimet Biosciences receives fast track designation from U.S. FDA for FASN inhibitor TVB-2640 in NASH
16 March 2021 - Sagimet Biosciences announced today that the U.S. FDA has granted fast track designation to TVB-2640 for ...
Posted by Michael Wonder on 17 Mar 2021
European Commission approves expanded indication for Merck’s Keytruda (pembrolizumab) in adult and paediatric patients with relapsed or refractory classical Hodgkin lymphoma
17 March 2021 - First Pediatric Indication for KEYTRUDA in the European Union. ...
Posted by Michael Wonder on 17 Mar 2021
U.S. plans to use real world and trial data to determine when vaccines need to be updated
17 March 2021 - U.S. officials plan to use data gathered from people who have already been vaccinated against COVID-19 as ...
Posted by Michael Wonder on 17 Mar 2021
Health Canada approves new indication for lung cancer treatment option Alunbrig
17 March 2021 - First-line indication offers Canadians with advanced lung cancer new treatment options. ...
Posted by Michael Wonder on 17 Mar 2021
Europe’s vaccine suspension may be driven as much by politics as science
16 March 2021 - Once it became clear Germany was pausing, the pressure mounted on other governments to hold off as ...
Posted by Michael Wonder on 17 Mar 2021
We are in the crisis of the century’: Europe threatens to seize AstraZeneca factories
18 March 2021 - Europe has threatened to seize AstraZeneca factories and strip the pharmaceutical giant of its intellectual property ...
Posted by Michael Wonder on 17 Mar 2021
AbbVie announces extension of review for supplemental new drug application of upadacitinib for the treatment of adults with active psoriatic arthritis
17 March 2021 - AbbVie announced that the U.S. FDA has extended the review period for the supplemental new drug application ...
Posted by Michael Wonder on 17 Mar 2021
Sparta Biomedical receives FDA breakthrough device designation for SBM-01 biomimetic implant
17 March 2021 - Sparta Biomedical today announced that its SBM-01 biomimetic implant has been granted a breakthrough device designation from ...
Posted by Michael Wonder on 17 Mar 2021
Leveraging real world evidence in regulatory submissions of medical devices
16 March 2021 - Among the many ways that the U.S. FDA protects and promotes the public health is by ensuring ...
Posted by Michael Wonder on 17 Mar 2021
Health Canada approves Increlex, first and only recombinant human insulin-like growth factor-1 therapy in Canada for the treatment of severe growth failure associated with ultra rare condition in children and adolescents
16 March 2021 - Ipsen Biopharmaceuticals today announced the commercial availability of Increlex (mecasermin) for the treatment of growth failure in ...
Posted by Michael Wonder on 16 Mar 2021
AstraZeneca vaccine fears may be more deadly than any side effect
16 March 2021 - In Europe, vaccination against COVID-19 is off to a worryingly slow start. Just 11 doses for every ...
Posted by Michael Wonder on 16 Mar 2021
Health Canada approves Perjeta for use pre-surgery in patients with aggressive early breast cancer
16 March 2021 - New approval provides Canadian patients with HER2 positive early breast cancer a proven treatment regimen in a ...
Posted by Michael Wonder on 16 Mar 2021
ATAGI statement in response to European decisions about the AstraZeneca vaccine
16 March 2021 - ATAGI notes the suspension of the AstraZeneca vaccine program in several European countries due to reports ...