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RSS FeedPosted by Michael Wonder on 25 Oct 2021
Biden speaks with potential FDA commissioner
25 October 2021 - President Joe Biden recently held a call with Dr. Rob Califf, the former FDA commissioner, who ...
Posted by Michael Wonder on 25 Oct 2021
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy as treatment for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer
22 October 2021 - Keytruda is now approved in combination with chemotherapy as first-line treatment for patients with locally recurrent unresectable ...
Posted by Michael Wonder on 24 Oct 2021
EU decision on Russia's Sputnik V shot 'impossible' this year
21 October 2021 - The EU drug regulator is unlikely to decide whether to approve Russia's Sputnik V coronavirus vaccine until ...
Posted by Michael Wonder on 23 Oct 2021
Sio Gene Therapies announces granting of FDA fast track designation for investigational AXO-AAV-GM1 (AAV9-GLB1) gene therapy in patients with GM1 gangliosidosis
21 October 2021 - Sio Gene Therapies today announced that the U.S. FDA has granted fast track designation to AXO-AAV-GM1, its ...
Posted by Michael Wonder on 23 Oct 2021
TGA to consider booster doses as health authorities assure the fully vaccinated that they are protected
23 October 2021 - Australia's medical regulator will look at new data from Pfizer on COVID-19 booster doses on Monday, with ...
Posted by Michael Wonder on 22 Oct 2021
Oncopeptides withdraws Pepaxto in US, scale down organisation and focus on R&D
22 October 2021 - Oncopeptides today announces that the company has decided to withdraw Pepaxto (melphalan flufenamide) from the market ...
Posted by Michael Wonder on 22 Oct 2021
Agenus provides update on balstilimab development
22 October 2021 - Company voluntarily withdraws biologics license application at FDA’s recommendation following full approval of pembrolizumab, which came four months ...
Posted by Michael Wonder on 22 Oct 2021
FDA approves Roche’s Susvimo, a first of its kind therapeutic approach for neovascular or “wet” age-related macular degeneration
22 October 2021 - Susvimo, previously called Port Delivery System with ranibizumab, is the first neovascular age-related macular degeneration treatment in ...
Posted by Michael Wonder on 21 Oct 2021
Ultimovacs receives dual FDA fast track designation for UV1 in advanced malignant melanoma
21 October 2021 - UV1 as add-on therapy to checkpoint inhibitors awarded fast track designation. ...
Posted by Michael Wonder on 21 Oct 2021
FDA issues draft guidance for industry on data standards for drug and biological product submissions containing real world data
21 October 2021 - Today, the U.S. FDA issued a draft guidance for industry titled Data Standards for Drug and Biological ...
Posted by Michael Wonder on 21 Oct 2021
FDA takes additional actions on the use of a booster dose for COVID-19 vaccines
20 October 2021 - Today, the U.S. FDA took action to expand the use of a booster dose for COVID-19 vaccines ...
Posted by Michael Wonder on 21 Oct 2021
Delivery of Novavax vaccine may be delayed in Australia due to reported manufacturing issues
21 October 2021 - Australians may not get access to the Novavax vaccine this year with reports of manufacturing problems causing ...
Posted by Michael Wonder on 21 Oct 2021
COVID-19 vaccine weekly safety report (21 October 2021)
21 October 2021 - To 17 October 2021, approximately 32.7 million vaccine doses have been given in Australia – 18.3 million ...
Posted by Michael Wonder on 21 Oct 2021
FDA grants breakthrough device designation for Biological Dynamics’ early stage pancreatic cancer detection test
20 October 2021 - Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita ...
Posted by Michael Wonder on 20 Oct 2021
Stealth BioTherapeutics receives refusal to file letter from the FDA
20 October 2021 - Stealth BioTherapeutics today announced that it received a Refusal to File letter from the United States FDA ...