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Drug Approvals

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Latest From Approvals

Keeping Track: A Duo Of RTOR Approvals, Thumbs Up For First Oral GLP-1 Treatment, And First Ebola Vaccine Nears US Market

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals

EMA OKs Seven New Drugs But Delivers Another Blow To Emmaus

Seven new drugs have this week moved closer to gaining EU approval following positive recommendations from the European Medicines Agency, but Emmaus’ glutamine product has fared less well and the company is considering another route for getting the drug to sickle cell disease patients in Europe

Europe Drug Review

Keeping Track: US FDA Approvals For Ibsrela, Gvoke And Nucala; A BTD For Tepotinib

The latest drug development news and highlights from our US FDA Performance Tracker. 
US FDA Performance Tracker Approvals

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

Europe Drug Review

Boehringer Avoids Further Efficacy Study Of Ofev In SSc-ILD With Full Approval, No Post-Marketing Commitments

Despite concerns from members of US FDA's Arthritis Advisory Committee that the efficacy profile of Boehringer Ingelheim's Ofev needs more study in the SSc-ILD indication, the company does not have any such postmarketing requirements or commitments.

Approvals Immune Disorders

Keeping Track: Ofev Snags SSc-ILD Indication, Accelerated Approval Reviews For Veverimer And Voxelotor, J&J Gets Its First Vaccine BTD

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals
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