The approval was based on safety and efficacy data from clinical trials evaluating diazepam rectal gel, as well as adult bioavailability studies comparing Libervant with diazepam rectal gel, adult and pediatric pharmacokinetic data, and an open-label safety study of Libervant.
Neurologic Disorders
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The closed-loop feature of the Inceptiv SCS senses neural responses and is able to automatically adjust stimulation in real time.
Prenatal opioid exposure not linked to a clinically meaningful increase in risk for neuropsychiatric disorders.
A phase 3, open-label study (MEND-PNPO) evaluating MC-1 in patients with confirmed PNPO deficiency (via genetic analysis) is currently in the works.
Risks increased for stroke, venous thromboembolism, myocardial infarction, heart failure, fracture, pneumonia, acute kidney injury.
Tavapadon is an oral, once-daily, selective dopamine D1/D5 receptor partial agonist designed to improve motor control while avoiding D2/D3 overstimulation.
LX2006 (AAVrh.10hFXN) is an adeno-associated virus gene therapy candidate designed to deliver a functional frataxin gene to cardiac cells to improve mitochondrial function.
Those treated with high-efficacy therapy while in the minimal disability state had largest reduction
Infusion increases on time without troublesome dyskinesia and reduces daily off time
Asthma treatment gains approval for severe cases in pediatrics; Dovato gains expanded indication; Decision taken to remove ALS drug from market; Complete Response Letter issued for apomorphine device; At-home Mpox test kit made available.
Xcopri tablets can be crushed and mixed with water to be taken as either an oral suspension or administered via a nasogastric tube.
The drug/device combination therapy provides a continuous subcutaneous infusion of apomorphine through an infusion pump.
First prescription smartphone app is approved for major depressive disorder; Novel blood test to detect TBI; Zevtera has been approved for bloodstream infections; The Mpox vaccine is now commercially available; Algorithm cleared for LVEF detection.
The Company has started the process with the Food and Drug Administration to discontinue marketing authorization for Reylvrio.
The prescribing information for Vigpoder carries a Boxed Warning associated with a risk for permanent vision loss.
The use of whole blood at the point of care eliminates the need for plasma extraction.
Intrathecal gene transfer with scAAV9/JeT-GAN may show some benefit in motor function for children with giant axonal neuropathy
The open-label, external placebo-controlled trial evaluated the efficacy and safety of Ultomiris in 58 adults with anti-AQP4 antibody positive NMOSD.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 EPIDYS study.
Postinfection incident neurologic diagnoses observed in 2.79 and 4.91% of COVID-19 and influenza cohorts, respectively.
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