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Health problems related to cosmetics are underreported

Many Adverse Events Related to Cosmetics Go Unreported

Cosmetics and personal care products get little regulatory scrutiny
Sales of reformulated Opana ER should be halted in the United States

FDA Requests Removal of Opana ER From Market

Agency says the medication's risk for abuse now outweighs any benefit
Keytruda (pembrolizumab) has been approved by the U.S. Food and Drug Administration to treat any cancer that has a certain genetic biomarker

FDA Approves Keytruda for All Cancers With Genetic Biomarker

First medication sanctioned for any cancer, regardless of origin
The injected drug Actemra (tocilizumab) has been approved by the U.S. Food and Drug Administration to treat adults with giant cell arteritis.

FDA Approves Actemra to Treat Giant Cell Arteritis

New indication provides the first FDA-approved therapy specific to this type of vasculitis
The U.S. Food and Drug Administration says it has expanded approval for the cystic fibrosis drug Kalydeco (ivacaftor) to include 33 mutations of the disease

FDA OKs Kalydeco for Additional Mutations in Cystic Fibrosis

Decision based on results of laboratory testing and previous clinical trials
A new medical device has been approved by the U.S. Food and Drug Administration to treat esophageal atresia.

FDA Approves New Device to Treat Esophageal Atresia

Device uses magnetic catheters to draw the upper and lower esophagus together
From 2001 to 2010

Postmarket Safety Events for 32 Percent of Novel Therapeutics

Thirty-two percent of 222 FDA approved novel therapeutics from 2001 to 2010 were affected
The first new drug to treat amyotrophic lateral sclerosis in more than 20 years has been approved by the U.S. Food and Drug Administration.

FDA Approves Radicava for Amyotrophic Lateral Sclerosis

Radicava, given intravenously, slows physical decline in patients with ALS
Brineura (cerliponase alfa) has been approved by the U.S. Food and Drug Administration to treat a specific form of Batten disease

Enzyme Replacement Drug OK’d for Form of Batten Disease

Brineura will be used to treat children with late infantile neuronal ceroid lipofuscinosis type 2 Batten
Rydapt (midostaurin) has been approved by the U.S. Food and Drug Administration

FDA Approves Kinase Inhibitor for Treatment of AML

Midostaurin, in combination with chemotherapy, treats acute myeloid leukemia in adults