Four million people are unable to tolerate one of the most common food allergies in the U.S. The allergy typically lasts a ...

Cytokinetics, Incorporated CYTK announced that the FDA has accepted the company’s new drug application (NDA) for lead ...

The U.S. Food and Drug Administration has approved a drug developed at Stanford Medicine that offers hope to people diagnosed ...

Johnson & Johnson JNJ announced that it has filed two supplemental biologics license applications (sBLA) seeking expanded use of its drug Tremfya in pediatric patients. While one sBLA seeks approval ...

Rezolute received an orphan-drug designation from the Food and Drug Administration for its treatment of hypoglycemia, or low blood sugar, caused by a disease in which a tumor produces too much insulin ...

In a new guidance statement, the American Diabetes Association advises against the use of unapproved products, warning of ...

The US Food and Drug Administration (FDA) has approved ustekinumab -kfce (Yesintek) as a biosimilar to ustekinumab (Stelara) for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, ...

As e-cigarettes have flooded the market, the FDA's role in approving new tobacco products is put under a microscope.

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are investigating a multistate ...

The median launch prices in the US increased from $29,630 (IQR, $1322-$49,691) for drugs approved in 201 to $84,240 (IQR, ...

This parasiticide product was previously approved for killing adult fleas ( Ctenocephalides felis ), treating and preventing ...

Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after ...