It's often tied to high blood pressure and type 2 diabetes, the FDA explained in a statement. “Previously, patients with NASH who also have notable liver scarring did not have a medication that ...
Instead, Galiatsatos said, the FDA approved the drug based on other signs of effectiveness, including whether patients were able to walk farther in six minutes than they could before they started ...
The Food and Drug Administration on Monday approved a gene therapy for metachromatic leukodystrophy, a devastating genetic disorder that eats away at affected children’s neurons. The medicine ...
About 6 million to 8 million people in the U.S. are thought to have NASH with moderate to advanced liver fibrosis, or scarring, the FDA says. Other complications associated with the condition ...
The FDA has approved the first gene therapy for children with a rare genetic disease called metachromatic leukodystrophy (MLD), which was made by a Boston-London biotech. The treatment ...
The FDA approved a new treatment for uncontrolled high blood pressure. The once-daily oral medication, called Tryvio (aprocitentan), is expected to be available in the second half of 2024.
HC Wainwright notes the FDA’s worries regarding the potential inability of children, particularly those under the age of 5, to process certain additives in the current medication formulation fully.
The FDA is also reviewing Biologics License Applications for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients ...
Instead, Galiatsatos said, the FDA approved the drug based on other signs of effectiveness, including whether patients were able to walk farther in six minutes than they could before they started ...