Drugs Receiving “Fast Track” Status Associated With Increased Safety Label Changes
A recent study examined whether expedited drug approvals have different rates of safety-related label changes compared with drugs approved through standard pathways.
Drug Approval
FDA Approves Mavyret for Treatment of Hepatitis C
Mavyret has been approved by the FDA to treat adults with certain types of chronic hepatitis C virus.
Radicava Approved to Treat Amyotrophic Lateral Sclerosis
Radicava, given intravenously, slows physical decline in patients with ALS.
First Drug to Treat Tardive Dyskinesia Approved by FDA
Ingrezza capsules were approved for treatment of adults with tardive dyskinesia.
FDA Approves ‘Bavencio’ for Merkel Cell Carcinoma Treatment
This drug targets the PD-1/PD-L1 pathway and is the first sanctioned treatment in the United States.
FDA Approves Noctiva to Treat Nocturnal Polyuria
This drug is designed to increase the absorption of water through the kidneys and decreasing urine production.
FDA Approves Xermelo for Carcinoid Syndrome Diarrhea
Oral tablets are to be used in combination with somatostatin analog therapy.
Trulance Now FDA Approved for Chronic Idiopathic Constipation
This drug is designed to stimulate secretions of intestinal fluid.
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