The approval is based on findings from the SERENA-6 Phase III trial.
The site supports low-to-high throughput production and increases AtomVie's manufacturing capacity more than tenfold.
The FDA is looking to modernise its regulatory framework for drugs derived from plants, algae, and fungi.
Ionis claims Zanvastro will become available to US patients with Alexander disease “in the coming weeks”.
The uptick in demand for HRT comes shortly after the FDA removed their long-standing associated black box label warning.
Superluminal Medicines will use the proceeds to advance its MC4R agonist candidate into Phase I trials by 2026.
