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RSS FeedPosted by Michael Wonder on 08 Oct 2021
ChemoCentryx announces FDA approval of Tavneos (avacopan) in ANCA associated vasculitis
8 October 2021 - First FDA approved orally administered inhibitor of the complement 5a receptor. ...
Posted by Michael Wonder on 08 Oct 2021
Recursion is granted FDA fast track designation for REC-2282 for the potential treatment of NF2 mutated meningiomas
7 October 2021 - Recursion today announced that the U.S. FDA has granted the company fast track designation for the ...
Posted by Michael Wonder on 08 Oct 2021
Health Canada approves the use of Rinvoq (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis
7 October 2021 - Authorization is based on the results from three Phase 3 multicenter, randomized, double-blind, placebo-controlled registrational clinical trials ...
Posted by Michael Wonder on 08 Oct 2021
Arcutis submits topical roflumilast cream new drug application to FDA for the treatment of adults and adolescents with plaque psoriasis
4 October 2021 - Roflumilast cream demonstrated statistically significant superiority over vehicle on the primary endpoint of IGA Success and statistically ...
Posted by Michael Wonder on 07 Oct 2021
BeiGene announces first regulatory approval in Australia for Brukinsa (zanubrutinib) for treatment of patients with Waldenström’s macroglobulinaemia
7 October 2021 - Represents Brukinsa’s second recent approval in the Asia-Pacific region, following October 1 approval in Singapore for treatment ...
Posted by Michael Wonder on 07 Oct 2021
The FDA should better regulate medical algorithms
7 October 2021 - Most do not require the agency’s approval, and those that do often don’t require clinical trials. ...
Posted by Michael Wonder on 07 Oct 2021
FDA still without a permanent leader as clock ticks down on acting head
7 October 2021 - The clock is ticking down on the time President Joe Biden has to appoint a permanent ...
Posted by Michael Wonder on 07 Oct 2021
Pfizer seeks US authorisation of Covid-19 vaccine for ages 5-11
8 October 2021 - The Pfizer vaccine could soon be available for children as young as five in the United States. ...
Posted 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. ...