Category archives for: FDA News

Sanofi and Regeneron Announce FDA Approval of Kevzara (sarilumab) for Rheumatoid Arthritis

PARIS and TARRYTOWN, N.Y., May 22, 2017 /PRNewswire/ — Sanofi and Regeneron Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) approval of Kevzara (sarilumab) for the treatment of adult patients with moderately to…

5 Tips for a Healthy Vacation

As you plan your next beach vacation, make sure your trip is a healthy one. Consider these five tips on sun safety, medications, contact lenses, tattoos, and eating well.

FDA Approves Actemra (tocilizumab) Subcutaneous Injection for Giant Cell Arteritis

May 22, 2017 — The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type…

FDA Expands Approved Use of Kalydeco to Treat Additional Mutations of Cystic Fibrosis

May 17, 2017 — The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication…

How to Safely Use Glucose Meters and Test Strips for Diabetes

The U.S. Food and Drug Administration regulates glucose meters and test strips. Check out this safety information from the FDA including advice on why you shouldn’t buy or sell previously owned test strips.

FDA Approves Merck’s Keytruda (pembrolizumab) as First-Line Combination Therapy for Patients with Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC), Irrespective of PD-L1 Expression

KENILWORTH, N.J.–(BUSINESS WIRE) May 10, 2017 –Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s anti-PD-1…

FDA Grants Accelerated Approval to Bavencio (avelumab) for Urothelial Carcinoma

May 9, 2017 — The U.S. Food and Drug Administration granted accelerated approval to avelumab (Bavencio, EMD Serono, Inc.) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following…

Medication Safety: Advice for New Moms

Mother’s Day is an exciting time for new moms. But moms (and dads) of babies 12 months and younger can also have some worries. Medical officers at the U.S. Food and Drug Administration offer health suggestions.

Giving Medication to Children

The director of FDA’s Office of Pediatric Therapeutics discusses what parents should know about medication. use in children.

FDA Approves Radicava (edaravone) to Treat Amyotrophic Lateral Sclerosis (ALS)

May 5, 2017 — The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. “After learning about the use of edaravone to…

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