The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...
The expanded indication allows esketamine nasal spray to be used as a standalone treatment in adults with MDD who have not ...
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
A University of Oklahoma professor and his team have discovered a new way to put atoms into drug molecules that could revolutionize the drug industry. The safer, cheaper, more environmentally friendly ...
The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.
A couple of University of Nebraska professors have launched a startup company with the goal of bringing to market an ...
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...