regulatory

News

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.

News

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.

News

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.

News

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.

News

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.

News

Australia stands firm on 'no' to Alzheimer's drug Leqembi

Eisai and Biogen have been unable to persuade Australia's medicines regulator to approve their Alzheimer's therapy Leqembi with a narrower label.

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

Australia stands firm on 'no' to Alzheimer's drug Leqembi

MIT team develops 'years-long' drug delivery tech

Health Trends 2025: Reimagining What's Possible

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