FDA Alerts
New Rx for Melanoma Approved
The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.
FDA Takes Action Against Georgia Dietary Supplement Manufacturer
A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease.
FDA Allows Marketing of Diabetes Test
Today, the U.S. Food and Drug Administration allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes.
FDA Approves New Rx to Treat a Form of Gaucher Disease
The U.S. Food and Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.
nSpired Natural Foods Recalls Products for Salmonella Risk
nSpired Natural Foods, Inc., has issued a voluntary recall of some of its nut-based products.
Baxter Recalls Dialysis Solution
Baxter International Inc. announced today it is voluntarily initiating a recall in the United States of two lots of DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level.
FDA Approves New Type of Sleep Medication
The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).
FDA Approves New Device to Preserve Donated Lungs
The US Food and Drug Administration (FDA) has approved a new device to preserve donated lungs. According to the agency, the device might lead to more lung transplants.
Cologuard Gets US Approval for Colorectal Cancer Screening
The U.S. Food and Drug Administration today approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.
FDA Approves Orbactiv to Treat Skin Infections
The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.