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A Milestone in Facilitating the Development of Safe and Effective Biosimilars

The 50th biosimilar approval milestone also reflects our strategic approach to biosimilars, as outlined in the FDA’s Biosimilars Action Plan.

Hilary marstonPatrizia cavazzoniSarah yimDrug administrationAssociation of accessible medicinesNew drug officeTherapeutic biologicsChief medical officerDrug evaluationBiologics price competitionInnovation actAccessible medicinesAction planBiosimilars action plan

FDA Roundup: April 26, 2024

FDA Roundup: April 26, 2024
bubblear.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from bubblear.com Daily Mail and Mail on Sunday newspapers.

United statesPmrs pmcsPatrizia cavazzoniSarah yimHilary marstonHuman servicesOffice of media affairsAccelerator applications united states incDay one biopharmaceuticals incUs department of healthCardinal healthDrug administrationEffective biosimilarsNew drug officeTherapeutic biologicsDrug evaluation

Eye on Pharma: Eylea Biosimilar Suspension; New FDA Labeling Guidance; Alvotech Reinspection

Samsung Bioepis suspends development for its biosimilar referencing Eylea (aflibercept); the FDA updates its labeling recommendations for interchangeable biosimilars; Alvotech receives a Form 483 after the FDA reinspected its Iceland-based manufacturing facility.

South koreaSamsung bioepi eyleaSamsung bioepiStantond alvotechSarah yimSamsung bioepisSamsung bioepis suspends aflibercept developmentBioprocess internationalKorean ministry of foodKorean ministryDrug safetyKorea biomedicalPharmaceutical affairsBiosimilarity statementNew drug officeTherapeutic biologics

Amgen Creates New Therapy Line - San Fernando Valley Business Journal

It's utilizing Horizon's drug development programs.

United statesRobert bradwayVikram karnaniSarah yimDrug administrationAmgen incHorizon therapeuticsThousand oaksUnited states foodChief executive robert bradwayDublin based horizon therapeuticsNew brunswickNew jersey based johnson

Amgen s Wezlana receives FDA approval to treat multiple inflammatory diseases

Amgen s Wezlana receives FDA approval to treat multiple inflammatory diseases
pmlive.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pmlive.com Daily Mail and Mail on Sunday newspapers.

Janssen stelaraSarah yimAmgen wezlanaNikolay nikolovDrug administrationJanssen pharmaceutical stelaraDrug evaluation

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