GSK Says US FDA Approved Its Twice-Annual Asthma Drug (1)

December 17, 2025, 8:09 AM UTC

GSK Plc said it won US approval for a drug to treat severe asthma, boosting its prospects as a potential blockbuster.

The US Food and Drug Administration approved Exdensur as an add-on maintenance treatment of severe asthma for patients aged 12 years and older, the company said in a statement on Wednesday.

It follows the European Medicines Agency backing the drug earlier this month, and the UK’s drug regulator has also given it the green light. Regulatory submissions are under review in China and Japan, GSK said.

The shares were up as much as 0.6% in early London trading. They ...

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