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Shingrix Shingles Vaccine: FDA Wants GSK To Monitor Inflammation Risk

 
• By Brenda Sandburg

GlaxoSmithKline's vaccine has 97.16% efficacy, surpassing Merck's Zostavax, but US advisory committee will weigh risks from inflammation which could cause ocular adverse effects and gout.

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GlaxoSmithKline Biologicals SA's shingles vaccine Shingrix appears on track for a positive review by a US FDA advisory panel as potential safety concerns are to be addressed in the company's pharmacovigilance plan.

FDA's briefing document for the Sept. 13 meeting of the Vaccines and Related Biological Products Advisory Committee notes...

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Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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Global Pharma Guidance Tracker - June 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
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