regulatory approval

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J&J has claimed FDA approval for Rybrevant Faspro, a subcutaneous version of the lung cancer therapy central to its blockbuster hopes for the drug.

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LIB Therapeutics has won FDA approval for a once-monthly cholesterol drug, Lerochol, that it says offers ease-of-use advantages over rivals.

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GSK scores a first approval in the UK for new severe asthma and CRSwNP therapy Exdensur, but a second in the US covers the asthma indication only.

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Allergy Therapeutics has had its grass pollen allergy treatment Grassmuno approved in Germany, its first market, setting up a launch early next year.

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Daiichi Sankyo and AstraZeneca's Enhertu has become the first new first-line option in the US for HER2-positive breast cancer in more than a decade.

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Flow Neuroscience has secured FDA approval for FL-100, the first at-home brain stimulation device for major depressive disorder.