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RSS FeedPosted by Michael Wonder on 21 Oct 2020
FDA approves fewer generics in FY2020, ending record streak
21 October 2020 - After four straight years of posting record numbers of abbreviated new drug application approvals, the US ...
Posted by Michael Wonder on 21 Oct 2020
U.S. FDA grants fast track designation for ASP0367/MA-0211, a selective PPARδ modulator being developed for the treatment of primary mitochondrial myopathies
20 October 2020 - Astellas Pharma today announced that the U.S. FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 21 Oct 2020
COVID-19 vaccines to be stored secretly under tight security
21 October 2020 - Drug makers and others plan to use fake shipments and GPS trackers to prevent potential thefts. ...
Posted by Michael Wonder on 21 Oct 2020
Trump’s antibody ‘cure’ will be in short supply
20 October 2020 - All the weak points of American health care — testing delays, communication breakdowns, inequity — are working ...
Posted by Michael Wonder on 21 Oct 2020
TG Therapeutics announces fast track designation granted by the FDA to ublituximab in combination with umbralisib for the treatment of adult patients with chronic lymphocytic leukaemia
21 October 2020 - TG Therapeutics today announced that the U.S. FDA has granted fast track designation to the combination of ...
Posted by Michael Wonder on 21 Oct 2020
Zosano Pharma receives complete response letter from FDA for Qtrypta
21 October 2020 - FDA feedback consistent with FDA’s preliminary communication in September. ...
Posted by Michael Wonder on 21 Oct 2020
Xeris Pharmaceuticals granted fast track designation by the FDA for its novel concentrated diazepam formulation (XP-0863) for injection
20 October 2020 - Xeris Pharmaceuticals today announced it was granted fast track designation by the FDA for the investigation ...
Posted by Michael Wonder on 21 Oct 2020
How the FDA stood up to the President
20 October 2020 - Dr. Stephen Hahn, the F.D.A. commissioner, occupies a fraught position, caught between pressure from the White House ...
Posted by Michael Wonder on 21 Oct 2020
Selecta Biosciences and AskBio receive FDA rare paediatric disease designation for their gene therapy for methylmalonic acidemia
20 October 2020 - Selecta Biosciences and Asklepios BioPharmaceutical today announced the U.S. FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 21 Oct 2020
California plans to review coronavirus vaccine independently
19 October 2020 - California is planning to review federally approved coronavirus vaccines independently before distributing it to residents, Governor ...
Posted by Michael Wonder on 20 Oct 2020
COVID-19 vaccines: time to talk about the uncertainties
20 October 2020 - Plan now for decisions on which vaccines should go to whom, when and how often. ...
Posted by Michael Wonder on 20 Oct 2020
Roche CEO warns against high hopes for speedy Covid vaccines
20 October 2020 - Many people’s hopes for a speedy coronavirus vaccine are still too high, Roche Holding AG Chief ...
Posted by Michael Wonder on 20 Oct 2020
Tagrisso granted priority review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
20 October 2020 - Unprecedented results show treatment with Tagrisso reduced the risk of disease recurrence or death by 80% in ...
Posted by Michael Wonder on 20 Oct 2020
Health Canada has approved Taltz (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis
19 October 2020 - Taltz is now approved to treat patients across the axSpA spectrum, including ankylosing spondylitis and non-radiographic axSpA. ...
Posted by Michael Wonder on 20 Oct 2020
Swissmedic fast-tracks second anti-viral vaccine
19 October 2020 - Swissmedic said the United States pharmaceutical company Pfizer submitted an application for the authorisation of a ...