Tag Archives: Approves

FDA Approves Ruzurgi (amifampridine) for Children with Lambert-Eaton Myasthenic Syndrome

FDA Approves Ruzurgi (amifampridine) for Children with Lambert-Eaton Myasthenic Syndrome Print this page May 06, 2019 — The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years to less than 17 years of age. This is the first FDA approval of a… Read More »

FDA Approves New Treatments Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) for Heart Disease Caused by Transthyretin Mediated Amyloidosis

Print this page May 06, 2019 — On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active… Read More »

Global Health: F.D.A. Approves the First Vaccine for Dengue Fever, but Limits Its Use

The Food and Drug Administration has approved the first vaccine for dengue, Dengvaxia, but placed significant restrictions on its use because the vaccine has been shown to put some people at heightened risk for a severe form of the disease. In clearing the vaccine, the agency acknowledged the serious public health benefit of slowing a… Read More »