Diacomit Approved for Younger Patients With Dravet Syndrome
Diacomit is available as 250mg and 500mg strength capsules in 60-count bottles and as fruit-flavored powder packets for oral suspension in 60-count cartons.
Neurologic Disorders
Ztalmy Oral Suspension Now Available for CDKL5 Deficiency Disorder
The approval was based on data from the phase 3 Marigold study that included patients aged 2 to 19 years with genetically confirmed CDKL5 gene mutation.
Natalizumab Biosimilar to Get FDA Review for MS, Crohn Disease Indications
The application is under review for relapsing forms of multiple sclerosis and Crohn disease.
![HYQVIA (immune globulin [human] 10% with recombinant human hyaluronidase) by Baxter and Halozyme](https://www.medicalbag.com/wp-content/uploads/sites/19/2022/07/hyqviaarticle_656631.png)
Hyqvia Reduces Relapse in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Trial
The ADVANCE-1 trial included adults with a confirmed diagnosis of CIDP who had remained on a stable dosing regimen of IVIG therapy for at least 3 months prior to screening.
Cannabis-Derived Oromucosal Spray Misses in MS Spasticity Trial
The RELEASE MSS1 trial included adults with a confirmed diagnosis of any disease subtype of multiple sclerosis.
Eplontersen Bests Placebo in Hereditary Transthyretin-Mediated Amyloid Polyneuropathy Study
Eplontersen is an investigational ligand-conjugated antisense medicine designed to reduce the production of TTR protein to treat both hereditary and nonhereditary forms of ATTR.
FDA Panel Votes on Pimavanserin for Alzheimer Disease Psychosis
Although not bound by the committee’s recommendations, the Agency does take them into consideration when making decisions on approval.
Crenezumab Misses Endpoints in Autosomal-Dominant Alzheimer Disease Trial
Crenezumab is an investigational monoclonal antibody designed to neutralize neurotoxic oligomers, a form of beta-amyloid.
Oral Treatment Radicava ORS Now Available for Patients With ALS
The oral suspension can be administered by mouth or via feeding tube using a 5mL oral syringe that comes with the product.
Vutrisiran to Undergo FDA Review for Polyneuropathy of Hereditary ATTR Amyloidosis
Vutrisiran is an investigational, subcutaneously-administered RNAi therapeutic designed to block the production of wild-type and mutant transthyretin protein.
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