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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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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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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

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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Global Pharma Guidance Tracker - April 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.

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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