regulatory

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Jean-François Toussaint, Sanofi's global head of vaccines R&D

FDA fast-tracks Sanofi's experimental chlamydia vaccine

Sanofi is preparing to start human testing of its chlamydia vaccine, now fast-tracked by the FDA, that it hopes will be the first to reach the market.

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FDA starts review of Sanofi's MS hope tolebrutinib

Sanofi's oral BTK inhibitor tolebrutinib is heading towards an FDA decision in September as a potential treatment for multiple sclerosis.

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EMA panel endorses AI for MASH clinical trials

PathAI's artificial intelligence tool for diagnosing MASH has become the first to be recommended under the EMA's Qualification Opinion framework.

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J&J's nipocalimab fast-tracked for Sjogren's disease

Johnson & Johnson's FcRn inhibitor nipocalimab has been awarded fast-track status by the FDA as a treatment for Sjogren's disease.

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FDA chooses flu vaccine strains despite cancelled meeting

The FDA has released its recommendations on the composition of influenza vaccines for the 2025-26 season – without the input of its external advisors.

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