The drug maker will respond to the USFDA within the prescribed timeframe and will work in close collaboration with it to ...
“I am gobsmacked that Lilly is seeking confidential patient medical records to build a case against the very therapies that ...
The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals' drug to treat stomach paralysis symptoms ...
Torrent Pharmaceuticals received a Form 483 with one observation from the USFDA after an inspection of its Pithampur ...
A D.C. drugmaker has been dealt a major setback in its long-running bid to bring its treatment for a chronic gastrointestinal ...
Torrent Pharmaceuticals, a leading player in the pharmaceutical industry, announced on Friday that it has received a Form 483 ...
Vanda said it will continue to pursue approval of tradipitant in gastroparesis, a condition that affects the stomach muscles and prevents proper stomach emptying, and that it plans to file a separate ...
Elanco Animal Health Incorporated (NYSE: ELAN) today announced the U.S. Food and Drug Administration (FDA) has approved ...
The U.S. Food and Drug Administration (FDA) has granted approval of 5 new prescription medications that are labeled for use ...
Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the“Company”), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today ...