The antisense oligonucleotide specialist is ready to launch its rare disease therapy Tryngolza but could face competition from a more potent rival by mid-2025.
Ionis has gained US Food and Drug Administration approval for Tryngolza, making it the first treatment in the US for the rare metabolic disease familial chylomicronemia syndrome (FCS), and giving it a head start over rival Arrowhead.
The US go-ahead was granted on 19 December, and Tryngolza (olezarsen) will be used an adjunct to diet to reduce...
The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.
The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.
