Arexvy was approved by the US FDA for adults 50-59 with medical conditions that put them at increased risk of severe RSV. Separately, the company ended a cancer deal with SpringWorks.

The company initiated a rolling submission with the US FDA for mirdametinib, a MEK inhibitor that is poised to be its second commercial product for a rare disease.

Resmetirom, which could become the first approved treatment for non-alcoholic steatohepatitis, is among 11 new drugs that the European Medicines Agency has started to review for potential EU approval. Meanwhile, a decision on whether to approve the drug in the US is due on 14 March.

US FDA’s 72 approvals under streamlined submission program consistently come before the PDUFA goal date, Pink Sheet analysis shows, but benefit ranges from 2 weeks for priority review novel agents to 1.8 months for other priority applications.