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 Assigns Priority Review for Elacestrant in Metastatic Breast CancerAugust 11th 2022
If approved, elacestrant would be the first oral selective estrogen receptor degrader (SERD) as a second- or third-line treatment for patients with ER+/HER2- advanced or metastatic breast cancer. The PDUFA date is Feb. 17, 2023.
Dr. Reddy’s Launches Prescription and Nonprescription GenericsAugust 1st 2022
The prescription drug launches include a therapy to treat adults with multiple myeloma and a treatment for overactive bladder. Dr. Reddy’s has also acquired several therapies from Eton Pharmaceuticals, including hypotension treatments.
FDA Accepts BLA for Immunotherapy for Bladder CancerJuly 29th 2022
If approved, N-803 — with the brand name Anktiva — plus the Bacillus Calmette-Guérin vaccine would be the first immunotherapy combination for this indication in 23 years. The Prescription Drug User Fee Act target action date is May 23, 2023.