FDA Approves Vaccine to Prevent Ebola Virus Disease

The U.S. Food and Drug Administration (FDA) has approved the first vaccine to prevent  Ebola virus disease. The vaccine, Ervedo, by Merck & Co, Inc, was granted approval based on a study conducted during the 2014-2016 outbreak in Guinea. The study involved 3,537...

FDA Committee Votes in Favor or New Epithelioid Sarcoma Treatment

The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) voted unanimously (11 – 0) in favor of approving tazemetostat to treat patients with epithelioid sarcoma.  The FDA is scheduled to make its decision for market approval on or...

Oxbryta (Voxelotor) to Treat Sickle Cell Disease

  Jonathan Sorof, MD of Global Blood Therapeutics (GBT) explains the mechanism of action of Oxbryta (voxelotor) to treat persons with sickle cell disease. Voxelotor blocks deoxygenated sickle hemoglobin polymerization and attenuates red blood cells from...

FDA Approves Second Exon-Skipping Drug for Duchenne

The U.S. Food and Drug Administration has approved Vyondys 53 (golodirsen) to treat patients with Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping. Golodirsen is an antisense oligonucleotide that can ‘skip’ over aspects of the RNA to make person’s with...

FDA Puts Hold on Trials for Rare Bone Disease

The U.S. Food and Drug Administration has issued a partial clinical hold in two studies underway to test palovarotene chronic treatment of fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas, respectively. The partial clinical hold is aimed at the...
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