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UCB : announces rozanolixizumab BLA for the treatment of generalized myasthenia gravis filed with U S FDA and designated for Priority Review

UCB announces rozanolixizumab BLA for the treatment of generalized myasthenia gravis filed with U.S. FDA and designated for Priority Review Biologic License. | January 6, 2023

Bruxelles capitaleCharl van zylJim baxterIris loew friedrichAntje witteLaurent schotsBrand communicationsEu internationalEuropean commissionDrug administrationNeurology solutions headCorporate communicationsMyasthenia gravis foundation of americaEuropean medicines agencyLancet reg health west pacCommittee for medicinal products human use

UCB announces U S FDA acceptance of new drug application and EMA MAA validation for zilucoplan for the treatment of generalized myasthenia gravis in adult patients

New drug application (NDA) for zilucoplan seeks approval for the treatment of generalized myasthenia gravis (gMG) in adult patients who are acetylcholine.

United kingdomBruxelles capitaleGreat britainDaphne teoCharl van zylJim baxterIris loew friedrichNeuromuscul disordAntje witteLaurent schotsUs communicationsBrand communicationsEu internationalEuropean commissionDrug administrationNeurology solutions head

AMGEN ANNOUNCES POSITIVE NEW DATA AT EADV 2022 FOR OTEZLA® (APREMILAST)

/PRNewswire/ Amgen (NASDAQ:AMGN) today announced results from two significant Phase 3 clinical studies of oral Otezla® (apremilast), demonstrating efficacy.

Puerto ricoUnited statesMichael strapazonJessica akopyanAnna belloni fortinaKyowa kirin co ltdEuropean academy of dermatologyDrug administrationBeigene ltdUniversity of padua medical schoolExchange commissionTherapeutics incNational psoriasis foundationTeneobio incDepartment of medicineChemocentryx inc

AMGEN TO PRESENT NEW, POSITIVE CLINICAL AND REAL-WORLD DATA ACROSS INFLAMMATION PORTFOLIO AT EADV 2022

New Positive Data From Phase 3 SPROUT Trial, Studying Otezla (apremilast) in Children Ages 6-17 With Moderate to Severe Plaque Psoriasis Positive .

Davidm reeseEuropean academy of dermatologyNew positive data from phaseStudying otezlaChildren agesIsevere plaque psoriasisResults fromInvestigating clinical efficacyPatients with moderateSevere genital psoriasisRocatinlimab phaseHighlight emerging clinical profileSevere atopicEuropean academyPresentation timesPediatric patients

Investegate |AstraZeneca PLC Announcements | AstraZeneca PLC: Update on US review of Fasenra in nasal polyps

Investegate announcements from AstraZeneca PLC, Update on US review of Fasenra in nasal polyps

United kingdomUnited statesClin otolaryngolAdrian kempWales nationalInvestor relations teamBiowa incKyowa kirin co ltdDrug administrationBiologics license applicationOrphan drug designationFast track designationRare diseasesAllergy clinSafety studyEmerging endotypes

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