regulatory approval

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LIB takes aim at cholesterol market with new PCSK9 option

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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UK, US approve GSK's twice-yearly asthma drug

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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Man sneezes and puts hand out to viewer to keep distance

Allergy Tx plots grass pollen jab launch after German okay

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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Enhertu moves into frontline breast cancer treatment

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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Woman wears neuro headset for depression

FDA clears first at-home device for depression

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

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FDA clears first gene therapy for rare genetic disease WAS

Fondazione Telethon's Waskyra has become the first gene therapy in the US for Wiskott-Aldrich syndrome, and the first taken to market by a non-profit.

LIB takes aim at cholesterol market with new PCSK9 option

UK, US approve GSK's twice-yearly asthma drug

Allergy Tx plots grass pollen jab launch after German okay

Enhertu moves into frontline breast cancer treatment

FDA clears first at-home device for depression

FDA clears first gene therapy for rare genetic disease WAS

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regulatory approval

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