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Ultomiris regulatory submission accepted under FDA Priority Review in the US for adults with generalised myasthenia gravis

Submission based on positive Phase III trial in which Ultomiris significantly improved functional activities as measured by Myasthenia Gravis-Activities of Daily Living Profile

United statesKuldigas novadsUnited kingdomRepublic of irelandMarc dunoyerNational organization for rare disordersCompany on twitterDrug administrationAlexion pharmaceuticals incInvestor relations teamEuropean unionNational institutes of neurological disordersYork academy of sciencesMyasthenia gravis activitiesDaily livingBiologics license application

UCB announces positive Phase 3 results for rozanolixizumab in generalized myasthenia gravis

/PRNewswire/ UCB, a global biopharmaceutical company, today announced positive topline results from the Phase 3 MycarinG study1 evaluating rozanolixizumab,.

United statesBruxelles capitaleSeanm healeySamantha mastersonNatalie jonesAntje witteLaurent schotsUniversity health networkBrand communicationsRare disease communicationsUniversity of torontoMyasthenia gravis foundation of americaEuropean unionDivision of neurologyCorporate communicationsLancet reg health west pac

Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines

Guidance on how to licence electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.

United kingdomNorthern irelandGreat britainElizabeth bakerEfua annoHealth ministersEuropean commission in eudralex volumeCompetent authorityEuropean commissionAssociation of great britainEuropean medicines agencyAdvertising standards authorityCommittee on toxicityUnited kingdom medical device regulationsProducts regulationsTobacco products

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