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RSS FeedPosted by Michael Wonder on 07 Oct 2021
FDA issues final order and guidance on surgical staplers and staples for internal use
7 October 2021 - Today, the U.S. FDA announced several actions related to surgical stapler and staple regulation and safety. ...
Posted by Michael Wonder on 07 Oct 2021
FDA recognises Memorial Sloan-Kettering database of molecular tumour marker information
7 October 2021 - Today, the FDA granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s ...
Posted by Michael Wonder on 07 Oct 2021
Mayne Pharma provides FDA update on generic Nuvaring
7 October 2021 - Mayne Pharma has received a complete response letter from the US FDA in relation to its ...
Posted by Michael Wonder on 07 Oct 2021
Joint statement: supply allocations of intravenous tocilizumab (Actemra) during serious shortage
7 October 2021 - Roche, the sponsor of tocilizumab (Actemra), notified the TGA of shortages of multiple presentations of tocilizumab ...
Posted by Michael Wonder on 07 Oct 2021
COVID-19 vaccine weekly safety report (7 October 2021)
7 October 2021 - To 3 October 2021, approximately 28.8 million vaccine doses have been given in Australia 17 million first ...
Posted by Michael Wonder on 07 Oct 2021
Moderna asks Health Canada to approve COVID-19 vaccine booster shot
5 October 2021 - Moderna has applied for Canadian approval of a third dose of its COVID-19 vaccine, the company ...
Posted by Michael Wonder on 06 Oct 2021
Acer Therapeutics and Relief Therapeutics announce FDA acceptance for filing of new drug application for ACER-001 to treat urea cycle disorders
6 October 2021 - FDA sets PDUFA target action date of June 5, 2022. ...
Posted by Michael Wonder on 06 Oct 2021
Complete response letter received from FDA
6 October 2021 - Requirement to address approvability issues identified by FDA ahead of NDA resubmission ...
Posted by Michael Wonder on 06 Oct 2021
Moderna announces European Medicines Agency authorises third dose of COVID-19 vaccine for immunocompromised individuals aged 12 years and older
5 October 2021 - Moderna today announced that the EMA has authorised a third dose of the Moderna COVID-19 vaccine (Spikevax) ...
Posted by Michael Wonder on 06 Oct 2021
EMA to consider rolling review for Merck's molnupiravir in coming days
5 October 2021 - The EMA will consider in the coming days whether to launch a rolling review of Merck's ...
Posted by Michael Wonder on 06 Oct 2021
Johnson & Johnson announces submission of emergency use authorisation amendment to the U.S. FDA to support booster of its single shot COVID-19 vaccine
5 October 2021 - Submission includes data showing a booster increased protection to 94% against moderate to severe/critical COVID-19 in the ...
Posted by Michael Wonder on 06 Oct 2021
Australian Government buys 300,000 doses of Merck COVID-19 treatment drug molnupiravir that has not yet been approved
5 October 2021 - While Australia is still trying to reach its COVID-19 vaccination targets, treatment options for the virus ...
Posted by Michael Wonder on 06 Oct 2021
Australia secures additional supplies of sotrovimab
4 October 2021 - The Australian Government has increased supplies of the promising COVID-19 treatment sotrovimab with over 15,000 additional doses ...
Posted by Michael Wonder on 06 Oct 2021
Amber Implants VCFix spinal system receives US FDA breakthrough designation
5 October 2021 - Set to vastly improve treatment of vertebral fractures. ...
Posted by Michael Wonder on 06 Oct 2021
US FDA grants fast track designation for JR-171 for the treatment of mucopolysaccaridosis type I
5 October 2021 - JCR Pharmaceuticals announced today that the US FDA has granted fast track designation for the investigational drug ...