Treatment with diroximel fumarate was associated with significantly fewer days of key gastrointestinal symptoms, according to topline results from a phase 3 study evaluating the GI tolerability.
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The FDA has expanded the approval of Darzalex (daratumumab; Janssen Biotech) to include use in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA; Allergan) for the treatment of upper limb spasticity in pediatric patients 2-17 years of age.
Adhansia XR (methylphenidate HCl extended-release capsules) is expected to be available as of July 15, 2019 for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older, according to Adlon Therapeutics.
The Drug Enforcement Agency (DEA) has designated Sunosi (solriamfetol; Jazz Pharmaceuticals) a Schedule IV controlled substance.
The FDA has expanded the approval of Lyrica (pregabalin; Pfizer) for pediatric patients 1 month of age and older as adjunctive therapy for the treatment of partial-onset seizures.
The Food and Drug Administration (FDA) has approved Nayzilam (midazolam) nasal spray for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity.
The FDA has approved Xeomin (incobotulinumtoxinA; Merz) as a first-line treatment for blepharospasm in adults.
The Food and Drug Administration (FDA) has approved Ruzurgi (amifampridine; Jacobus Pharmaceutical) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to <17 years of age.