FDA Clears Rapid Blood Test for Mild Traumatic Brain Injury
The test measures glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase L1, biomarkers present in blood plasma at elevated concentrations after a brain injury.
All articles by Brian Park, PharmD
Mirabegron Granted Priority Review for Neurogenic Detrusor Overactivity
The submissions are supported by data from a phase 3 study that evaluated mirabegron in 91 patients aged 3 to 17 years with NDO on clean intermittent catheterization.
FDA Strengthens REMS for Transmucosal Immediate-Release Fentanyl Products
While the use of TIRF medications has declined in recent years, data have suggested that prescribing of these drugs to patients who are not opioid tolerant still remains.
FDA Approves Shorter Infusion Time for MS Drug Ocrevus
The approval was based on data from the phase 3b ENSEMBLE PLUS study that compared the frequency and severity of infusion-related reactions for a 2-hour Ocrevus infusion time to the previously approved 3.5-hour infusion time in patients with relapsing-remitting MS.
Hetlioz Approved for Nighttime Sleep Disturbances in Smith-Magenis Syndrome
The approval was based on data from a 9-week, double-blind, placebo-controlled, crossover study which assessed the effects of Hetlioz in patients with SMS.
Trehalose Designated Orphan Drug for ALS
SLS-005 contains the active ingredient trehalose, a low molecular weight disaccharide that crosses the blood brain barrier, stabilizes proteins and activates autophagy.
Room Temperature Stable Fosphenytoin Gets FDA Approval
The product is a ready-to-dilute, room temperature stable formulation of fosphenytoin for IV injection, which allows for point-of-care storage.
NDA Submitted for Novel Intranasal DHE for Migraine
INP104 uses proprietary technology to deliver a lower dose (1.45mg) of dihydroergotamine mesylate (DHE) to the upper nasal space.
FDA Authorizes Digital Therapeutic for Sleep Disturbance in PTSD
NightWare is a smartwatch application that uses the Apple Watch and Apple iPhone platform.
Brilinta Approved to Reduce Risk of Recurrent Stroke in High-Risk Patients
The approval was based on data from the phase 3 THALES trial (N=11,016) that compared treatment with ticagrelor plus aspirin to aspirin alone in preventing new stroke events.
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