The FDA has approved the supplemental New Drug Application for Tiglutik oral suspension to include administration via percutaneous endoscopic gastrostomy (PEG) tubes for the treatment of amyotrophic lateral sclerosis.
The FDA has expanded the indication for Toujeo (insulin glargine; Sanofi) 300 Units/mL to include treatment of pediatric patients aged ≥6 years with diabetes mellitus.
The Food and Drug Administration (FDA) has launched CURE ID, an internet-based repository that allows clinicians to report their experiences using existing FDA-approved drugs for difficult-to-treat infections.
The Food and Drug Administration (FDA) has issued a warning letter to Greenbrier International for receiving over-the-counter (OTC) drugs produced by foreign manufacturers with multiple violations of current good manufacturing practices (CGMP).
The New Drug Application (NDA) for viloxazine hydrochloride (SPN-812; Supernus Pharmaceuticals), a serotonin norepinephrine modulating agent, has been submitted to the Food and Drug Administration (FDA) for the treatment of pediatric patients with attention deficit hyperactivity disorder (ADHD).
The Nonprescription Drugs Advisory Committee (NDAC) of the Food and Drug Administration (FDA) has recommended the approval of the New Drug Application (NDA) from GlaxoSmithKline for an over-the-counter (OTC) nicotine mouth spray to aid in smoking cessation (9 to 6 vote). The nicotine mouth spray (NMS) delivers 1mg nicotine per spray; each dispenser would deliver…
The Food and Drug Administration (FDA) has granted Fast Track designation to ANX005 (Annexon Biosciences) for the treatment of Guillain-Barré Syndrome (GBS), an autoimmune disease that can lead to widespread peripheral nerve damage and paralysis.
