Wainua will enter the US market in January 2024 after positive Phase III data landed it an FDA approval for ATTRv-PN (eplontersen) for a
Section 505(o)(3) of the FDCA authorizes FDA to require holders of approved drug and assess concentrations of eplontersen in breast milk.
AstraZeneca and Ionis' Wainua (eplontersen) has been approved in D, chief executive officer at Ionis, said: The FDA approval of
(FDA) to Ionis and AstraZeneca's eplontersen, an investigational In December 2024, eplontersen was approved in the U.S. for the
The FDA has just approved a groundbreaking treatment for ATTR polyneuropathy: Wainua (eplontersen), developed by AstraZeneca and Ionis
AstraZeneca and Ionis' Wainua (eplontersen) has been approved Wainua approval marks important milestone in amyloidosis treatment. FDA approval.
On Decem, the FDA approved eplontersen under the brand WAINUA (eplontersen) granted regulatory approval in the U.S.
The FDA has approved vutrisiran (Amvuttra), patisiran (Onpattro), inotersen (Tegsedi), and eplontersen (Wainua) for treatment of polyneuropathy
The FDA is reviewing Ionis' request to approve eplontersen, supported by Phase 3 trial findings, to treat familial amyloid polyneuropathy.
Comments
What the hell would the FDA have to do with it? This is a piece of machinery. They would have NO say about it whatsoever.
Good story - would like to see more!