FDA issues Ipsen Biopharmaceuticals a complete response letter on its NDA for palovarotene, an investigational treatment for reducing new abnormal bon...
FDA publishes a draft guidance updating with GDUFA 3 commitments a 2020 guidance on generic drug development controlled correspondence.
FDA launches a digital technology Leadership Modernization Action Plan.
FDA releases the form FDA-483 issued following an inspection at the Goa, India-based Glenmark Pharmaceuticals drug manufacturing facility.
FDA approves a Foundation Medicine blood-based companion diagnostic for Genentechs cancer drug Rozlytrek.
Public Citizen calls on FDA to postpone a 1/6-expected accelerated approval decision on a Biogen/Eisai Alzheimers drug until after an advisory committ...
The Biotechnology Innovation Organization suggests modifications to an FDA draft guidance on measuring growth and evaluating pubertal development in p...
FDA accepts for review an AstraZeneca BLA for nirsevimab for preventing respiratory syncytial virus lower respiratory tract disease in newborns and in...
