Since the May recall, Glenmark told regulators it has received reports of three deaths, three hospitalizations, and four ...
The FDA's top food official says the safety of the dye called Red 40 hasn't been assessed in over a decade, despite concerns ...
The more than 233,000 bottles of duloxetine contain the "presence" of nitrosamine drug substance impurity, ...
233,003 bottles of duloxetine have been recalled due to potentially containing high levels of cancer-causing impurities.
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
An SNRI (serotonin and norepinephrine reuptake inhibitor) is one of two major classes of medications used to treat clinical ...
The U.S Food and Drug Administration said on Friday it has approved Checkpoint Therapeutics' drug for treatment of a type of ...
The US Food and Drug Administration (FDA) has approved nemolizumab for moderate-to-severe atopic dermatitis inadequately ...
The immediate aftermath of the 2024 presidential election has brought renewed attention to regulatory policy at the U.S. Food ...
The U.S. Food and Drug Administration has approved Neurocrine Biosciences' drug to treat a type of genetic disorder, the ...