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RSS FeedPosted by Michael Wonder on 19 Feb 2021
Clinical decision support software
18 February 2021 - From 25 February 2021, the way that software-based medical devices are regulated in Australia will change. ...
Posted by Michael Wonder on 19 Feb 2021
Where is AstraZeneca’s vaccine? Health Canada says not yet ready to greenlight
18 February 2021 - Health Canada is not yet ready to make a decision about approving the COVID-19 vaccine from ...
Posted by Michael Wonder on 19 Feb 2021
Efanesoctocog alfa granted FDA fast track designation for treatment of haemophilia A
18 February 2021 - Efanesoctocog alfa, previously known as BIVV001, is an investigational factor VIII replacement therapy that has the potential ...
Posted by Michael Wonder on 18 Feb 2021
Additive Orthopaedics announces FDA approval of patient specific talus spacer, first approved in the U.S.
17 February 2021 - Company can now initiate commercial marketing, sale, and distribution of patient specific talus spacer implants. ...
Posted by Michael Wonder on 18 Feb 2021
Viatris launches Hulio (adalimumab biosimilar) in Canada
18 February 2021 - Viatris announced today that Health Canada has approved Hulio, and product is now available in Canada. ...
Posted by Michael Wonder on 18 Feb 2021
Coherus BLA filing for adalimumab biosimilar candidate accepted by FDA for review
17 February 2021 - Coherus BioSciences announced that the United States FDA has accepted for review the 351(k) biologics license application ...
Posted by Michael Wonder on 18 Feb 2021
Johnson & Johnson has only a few million COVID-19 vaccine doses in stock as likely launch nears
18 February 2021 - Johnson & Johnson has only a few million doses of its experimental COVID-19 vaccine in its ...
Posted by Michael Wonder on 18 Feb 2021
Astellas and Seagen announce submission of two supplemental biologics license applications to the U.S. FDA for Padcev (enfortumab vedotin-ejfv) in locally advanced or metastatic urothelial cancer
18 February 2021 - Submissions will be reviewed under Real-Time Oncology Review based on clinical trials EV-301 and cohort 2 of ...
Posted by Michael Wonder on 18 Feb 2021
Pfizer and BioNTech to supply the European Union with 200 million additional doses of Cominarty
17 February 2021 - New agreement brings total supply to the European Union to 500 million doses, with delivery expected by ...
Posted by Michael Wonder on 18 Feb 2021
Ultragenyx announces approval of Dojolvi (UX007/triheptanoin) in Canada for the treatment of long-chain fatty acid oxidation disorders in adults and children
17 February 2021 - First approved treatment for adult and paediatric patients with long-chain fatty acid oxidation disorders in Canada. ...
Posted by Michael Wonder on 17 Feb 2021
Axonics receives FDA approval for third generation implantable neurostimulator
16 February 2021 - Axonics Modulation Technologies has received PMA supplement approval from the U.S. FDA for its third generation implantable ...
Posted by Michael Wonder on 17 Feb 2021
Verrica Pharmaceuticals announces FDA filing acceptance of resubmitted new drug application for VP-102 for the treatment of molluscum contagiosum
17 February 2021 - PDUFA goal date assigned is 23 June 2021. ...
Posted by Michael Wonder on 17 Feb 2021
BeiGene announces U.S. FDA acceptance of supplemental new drug application for Brukinsa (zanubrutinib) in Waldenström’s macroglobulinaemia
17 February 2021 - BeiGene today announced that the U.S. FDA has accepted a supplemental new drug application for Brukinsa (zanubrutinib) ...
Posted by Michael Wonder on 17 Feb 2021
FDA approves first in the world, first-of-its-kind implant for the treatment of rare bone disease as a humanitarian use device
17 February 2021 - Today, the U.S. FDA approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use. ...
Posted by Michael Wonder on 17 Feb 2021
COVID-19 vaccine approval process: does it take too long?
15 February 2021 - Here are answers to some questions about the FDA review panels. ...