Advertisement
Home Tags Food & Drug Administration

Tag: Food & Drug Administration

The U.S. Food and Drug Administration plans to begin a public dialogue about reducing nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards

FDA Proposes Lowering Nicotine Levels in Cigarettes

0
Goal is to combat smoking by making it less addictive
The first magnetic resonance imaging device designed specifically for neonatal brain and head imaging in intensive care units has been approved by the U.S. Food and Drug Administration.

FDA Approves First Neonatal MRI Device

0
Device designed for neonatal brain and head imaging in intensive care units
Nerlynx (neratinib) has been approved by the U.S. Food and Drug Administration to help prevent human epidermal growth factor receptor type 2-positive breast cancer from returning.

FDA Approves Nerlynx to Help Prevent HER2+ Breast CA Return

0
Drug is a kinase inhibitor that works by blocking several enzymes that promote cell growth
The potential first gene therapy in the United States is being reviewed by a U.S. Food and Drug Administration expert panel.

Potential First U.S. Gene Therapy Now Under FDA Review

0
Tisagenlecleucel could be a one-time treatment for children and young adults with advanced leukemia
The U.S. Food and Drug Administration has approved Endari (L-glutamine oral powder) to treat patients with sickle cell disease.

FDA Approves Endari for the Treatment of Sickle Cell Disease

0
First treatment approved for patients with sickle cell disease in almost 20 years
A cooling cap approved in 2015 for use in breast cancer patients has received expanded approval from the U.S. Food and Drug Administration.

FDA Expands Use of Cooling Cap to Cut Chemo-Related Hair Loss

0
Treatment now approved for patients receiving chemotherapy for solid tumors
Health problems related to cosmetics are underreported

Many Adverse Events Related to Cosmetics Go Unreported

0
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

0
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

0
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

0
New indication provides the first FDA-approved therapy specific to this type of vasculitis