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 ...
The US Food and Drug Administration has approved a fusion protein made by Merck & Co. for a rare, life-threatening lung disorder. The drug, called sotatercept and set to be marketed under the name ...
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 ...
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 approval makes ravulizumab the first and only long-acting C5 complement inhibitor for this indication and is supported by data from the phase 3 CHAMPION-NMOSD trial (NCT04201262), published in ...
When a soldier is rushed to medical care following a blast or other injury to the head, time is crucial in deciding just how extensive that injury is. Now, the U.S. Army has announced that the U.S ...
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 ...