FDA delays the PDUFA action date for Junshi Biosciences toripalimab because Covid travel restrictions involving China are preventing a needed facility...
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FDA publishes a draft guidance updating with GDUFA 3 commitments a 2020 guidance on generic drug development controlled correspondence.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The Biotechnology Innovation Organization suggests modifications to an FDA draft guidance on measuring growth and evaluating pubertal development in p...
