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Keeping Track: GSK’s Priorix Makes Three Novel US FDA CBER Approvals In 2022; Two CV Drugs Among Recent NDAs

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

The US FDA Center for Biologics Evaluation and Research approved its third novel biologic of 2022 on 3 June, clearing GlaxoSmithKline plc’s measles, mumps and rubella vaccine Priorix late in the day.

Priorix will mark the US debut of a vaccine that has been available for 20 years in Europe, joining a well-established market, in contrast the other novel vaccine approved by CBER in 2022 – Moderna, Inc

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
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