All The US Food and Drug Administration (FDA) articles – Page 3
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NewsSwitzerland and US sign drug inspection agreement
To promote Good Manufacturing Practice, Switzerland and the US have signed a Mutual Recognition Agreement to improve pharmaceutical drug inspection.
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NewsEisai submits MAA for lecanemab in Europe
A Marketing Authorisation Application for lecanemab to treat Alzheimer's has been submitted to the European Medicines Agency.
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NewsPotential blockbuster drugs to watch in 2023
Lecanemab for Alzheimer's and the first potential gene therapy primed for US launch for haemophilia A are two potential blockbuster Drugs to Watch™, says a 2023 report.
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NewsFDA grants accelerated approval for Leqembi
Alzheimer’s drug Leqembi has been accepted via the US Food and Drug Administration (FDA)’s Accelerated Approval pathway.
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NewsFDA accepts Biologics License Application for RSV vaccine
The Biologics License Application for nirsevimab as the first protective option against RSV for all infants has been accepted by the the US Food and Drug Administration (FDA).
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NewsFirst treatment approval for advanced ASPS
A Phase II trial has led to the FDA approval of atezolizumab for individuals over two years old with advanced alveolar soft part sarcoma.
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