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RSS FeedPosted by Michael Wonder on 24 Nov 2020
Telix new drug application for prostate cancer imaging product accepted by US FDA
24 November 2020 - Telix Pharmaceuticals announces new drug application for TLX591-CDx. ...
Posted by Michael Wonder on 24 Nov 2020
Success for a third—and perhaps most important—COVID-19 vaccine
23 November 2020 - The AstraZeneca-Oxford jab is likely to be widely used around the world. ...
Posted by Michael Wonder on 24 Nov 2020
Merck submits applications for licensure of V114, the company’s investigational 15 valent pneumococcal conjugate vaccine, for use in adults to the US FDA and EMA
23 November 2020 - Merck today announced the company has submitted applications to the US FDA and EMA for licensure of ...
Posted by Michael Wonder on 24 Nov 2020
FDA approves first drug to treat rare metabolic disorder
23 November 2020 - Today, the U.S. FDA approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1, a ...
Posted by Michael Wonder on 24 Nov 2020
Rigel and Medison announce Health Canada approval of Tavalisse, an oral medication for the treatment of adults with chronic immune thrombocytopenia
23 November 2020 - Rigel Pharmaceuticals and Medison Pharma today announced that Health Canada has approved the new drug submission ...
Posted by Michael Wonder on 24 Nov 2020
VBI Vaccines announces submission of marketing authorisation application for 3 antigen prophylactic hepatitis B vaccine to the European Medicines Agency
23 November 2020 -VBI Vaccines today announced the submission of a marketing authorisation application to the EMA for the Company’s ...
Posted by Michael Wonder on 23 Nov 2020
Workshop on regulatory support for development of orphan medicines
23 November 2020 - On Monday, 30 November, EMA is hosting a workshop to discuss the benefits and impact of ...
Posted by Michael Wonder on 23 Nov 2020
COVID-19 shots could reach first Americans by mid-December, top health official says
23 November 2020 - U.S. health care workers and others recommended for the nation’s first COVID-19 inoculations could start getting shots ...
Posted by Michael Wonder on 23 Nov 2020
Theralase granted FDA fast track designation for NMIBC Phase 2 clinical study
23 November 2020 - Theralase Technologies announced today that the U.S. FDA has granted Theralase fast track designation for its ...
Posted by Michael Wonder on 23 Nov 2020
AB201 development as a potential treatment for COVID-19 receives U.S. FDA fast track designation
23 November 2020 - AB201 is the only novel compound being developed for COVID associated coagulopathy. ...
Posted by Michael Wonder on 23 Nov 2020
Kiniksa announces U.S. FDA acceptance of sBLA and priority review for rilonacept in recurrent pericarditis
23 November 2020 - Filing based on positive data from RHAPSODY, which achieved its primary and all major secondary endpoints. ...
Posted by Michael Wonder on 23 Nov 2020
Catalent signs commercial supply agreement with Blueprint Medicines following FDA approval of Gavreto (pralsetinib)
23 November 2020 - Catalent today announced that it had entered into a commercial supply agreement with Blueprint Medicines following FDA ...
Posted by Michael Wonder on 23 Nov 2020
FDA expands approval of influenza treatment to post-exposure prevention
23 November 2020 - Today, the U.S. FDA expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of ...
Posted by Michael Wonder on 23 Nov 2020
European Commission approves MenQuadfi, the latest innovation in meningococcal vaccination for individuals 12 months of age and older
23 November 2020 - EC approval based on robust data from seven pivotal Phase 2 and 3 trials involving more than ...
Posted by Michael Wonder on 23 Nov 2020
Politics, science and the remarkable race for a coronavirus vaccine
21 November 2020 - The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical ...