Tag: FDA

A total of 108 posts are filed under FDA
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FDA Awards KGI an Orphan Drug Designation for Rett Syndrome
A project that was part of Dr. Ian Phillips’ Writing an Orphan Drug Application (ALS 432) class recently led to the U.S. Food and Drug… Continue Reading
The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly.    REUTERS/Jason Reed   (UNITED STATES HEALTH) - RTXQCTX
Rare Disease Report: FDA Approves Combination Letairis and Adcirca for PAH
The U.S. Food and Drug Administration (FDA) has approved the combination of Letairis (ambrisentan) and Adcirca (tadalafil) to treat patients… Continue Reading
FDA Awards 18 Grants to Stimulate Product Development for Rare Diseases
The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the… Continue Reading
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Rare Disease Report: Raptor’s Cysteamine Capsule Now Approved for Children
Children with nephropathic cystinosis can now receive delayed-release cysteamine tablets. Raptor Pharmaceutical Corp announced that the U.S.… Continue Reading
Genentech on the Verge of First Biologic Treatment for Pemphigus Vulgaris
Genentech has announced the initiation of a Phase III clinical trial investigating the use of Rituxan (rituximab) in patients with pemphigus… Continue Reading
RARECast: An FDA Perspective on Rare Diseases
  The FDA Office of Orphan Products Development seeks to advance the evaluation of drugs and diagnostics to treat rare diseases. A growing… Continue Reading
Girl With Duchenne Waits for Life-Changing Drug, Eteplirsen, To Gain FDA Approval
Susie Arroyo knows she is an anomaly. The 25-year-old Pendleton woman has a genetic mutation called Duchenne Muscular Dystrophy, a… Continue Reading

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