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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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FDA starts review of Roche's Gazyva in lupus nephritis

FDA starts a review of Roche's Gazyva as a treatment for lupus nephritis, an indication that analysts think could unlock renewed sales growth.

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Lawrence Tallon will lead MHRA after June Raine retires

Lawrence Tallon has been named head of the MHRA, effective 1st April, replacing Dame June Raine who is retiring.

FDA starts review of Sanofi's MS hope tolebrutinib

EMA panel endorses AI for MASH clinical trials

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

FDA chooses flu vaccine strains despite cancelled meeting

FDA starts review of Roche's Gazyva in lupus nephritis

Lawrence Tallon will lead MHRA after June Raine retires

Ambrosia's sweet $100m round, and other biofinancings

Using AI-driven synthetic personas to take your insights fur...

regulatory

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