These Food and Drug Administration (FDA) approvals were recently announced:
On February 26, 2021, the FDA approved a new drug application for Nulibry (fosdenopterin; Origin Biosciences Inc.) to reduce the risk of of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. MoCD Type A is a rare, genetic, metabolic disorder that typically presents in the first few days of life, causing intractable seizures, brain injury and death. Patients with MoCD Type A cannot produce cyclic pyranopterin monophosphate (cPMP). Nulibry is an intravenous medication that replaces the missing cPMP. More information.
Hominis Surgical System
On March 1, 2021, the FDA granted a de novo marketing authorization for the Hominis Surgical System, a robotically-assisted surgical device that can help facilitate transvaginal hysterectomy in certain patients. The Hominis Surgical System is intended for benign hysterectomy with salpingo-oophorectomy. The Hominis Surgical System uses minimally-invasive surgical instruments inserted through the vagina and a video camera inserted laparoscopically through a small incision on the abdomen for visualization of the instruments inside the patient. The transvaginal approach requires fewer incisions on the abdomen compared to conventional laparoscopic hysterectomy. More information.