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Despite unprecedented events in public health and politics, the US Food and Drug Administration’s 2021 story about novel agent approvals hit some familiar (but nonetheless impressive) notes: another y
AstraZeneca’s Anifrolumab For Systemic Lupus Erythematosus PDUFA Date: 5 July A decision from the US Food and Drug Administration is imminent for AstraZeneca PLC ’s anifrolumab for the treatment of
NDA and BLA submission news made up for a quiet week on the approvals front at the US Food and Drug Administration. Infectious disease patients saw three recent submissions, all representing different
Atox Bio aims to submit an New Drug Application for its necrotizing soft tissue infections (NSTI) therapy to US regulators in September under the accelerated approval pathway there despite the drug m