Tag: FDA

A total of 112 posts are filed under FDA
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Marathon Pharmaceuticals Announces Submission of Deflazacort New Drug Application to the FDA
Marathon Pharmaceuticals, LLC, a biopharmaceutical company developing treatments for rare diseases, today announced it has submitted a New… Continue Reading
Intercept’s Liver Drug Wins FDA Approval To Treat Rare Disease
The FDA ended a busy week by giving a thumbs-up late Friday to obeticholic acid as a treatment for primary biliary cirrhosis, a rare… Continue Reading
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Rare Disease Report: FDA Expands Keytruda Indication for Advanced Melanoma
The FDA has approved an expanded indication for Keytruda (pembrolizumab), an anti-PD-1 (programmed death receptor-1) therapy, to include it… Continue Reading
CureDuchenne Responds to FDA Advisory Committee Meeting on Drisapersen for Duchenne Muscular Dystrophy
CureDuchenne, the California-based nonprofit organization dedicated to finding cures for Duchenne muscular dystrophy, released the… Continue Reading
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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