Keeping Track: Jardiance Approved Across Heart Failure Spectrum, But US FDA Turns Down Bardoxolone, Terlipressin
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Reata’s Skyclarys Approval Aided By Natural History And Delayed-Start Analyses
The first treatment for the rare neurodegenerative disorder Friedreich’s ataxia relied on a single placebo-controlled efficacy trial.
Lilly Pulls EU Approval Application For Olumiant In COVID-19
The European Medicines Agency says it does not have enough data to justify the approval of Olumiant for hospitalized COVID-19 patients. The marketing authorization application for another product, Reata’s Imbarkyd for chronic kidney disease, has also been withdrawn.
Political Trials On All Sides: Lilly CEO Laments Loss Of ‘Chamber of Commerce Republicans’
David Ricks says the challenging political environment is empowering regulators. The Lilly leader also talked Twitter and drug prices, in a STAT Summit interview.