FDA Approves Rolvedon to Prevent Chemotherapy-related InfectionsSeptember 11th 2022
Rolvedon, which previously had the brand name Rolontis, is the first novel long-acting GCSF product approved in more than 20 years. Spectrum Pharmaceuticals expects it to be available in the fourth quarter.
FDA Advisory Committee Supports Approval of AMX0035 for ALSSeptember 8th 2022
In a second committee meeting, FDA advisors supported approval of AMX0035 after the company presented additional analysis of phase 2 data of AMX0035 to treat patients with ALS. The Prescription Drug User Fee Act (PDUFA) target action date is Sept. 29, 2022.
FDA Approves Xenpozyme for ASMD, a Rare Genetic DisorderSeptember 1st 2022
Xenpozyme, the first disease-specific treatment for acid sphingomyelinase deficiency (ASMD), is expected to be available in the United States in the coming weeks at a wholesale acquisition cost of $7,142 per vial.