Ongentys Now Available as Add-On Treatment for Parkinson Disease
Ongentys is an oral, selective and reversible inhibitor of catechol-O-methyltransferase.
All articles by Brian Park, PharmD
FDA Approves Radioactive Diagnostic Agent for Neuroendocrine Tumors
Detectnet (copper Cu 64 dotatate) is indicated for use with PET for localization of somatostatin receptor positive neuroendocrine tumors.
New Drug Application for Apomorphine Infusion Pump Submitted for Review
The NDA for SPN-830 is supported by data from an extensive development program that includes the phase 3 TOLEDO study and a supportive open-label study.
FDA: Stimulation Trial Should Be Performed Before Implanting SCS for Pain
The FDA reported that between July 27, 2016 and July 27, 2020, a total of 107,728 medical device reports (MDRs) associated with SCS devices intended for pain were received.
Qdolo Approved for Pain Management
Qdolo contains tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin reuptake.
Bafiertam Now Available for Relapsing Forms of Multiple Sclerosis
Bafiertam is a novel fumarate bioequivalent alternative to its prodrug dimethyl fumarate.
Confirmatory Testing No Longer Needed for 23andMe’s CYP2C19 Report
The 510(k) clearance allows for modification of the labeling of the previously authorized pharmacogenetics report.
Casimersen Gets Priority Review for Duchenne Muscular Dystrophy
Casimersen is a phosphorodiamidate morpholino oligomer that works by binding to exon 45 of dystrophin pre-mRNA.
Orphengesic Forte Now Available for Pain Management
The safety of long-term Orphengesic Forte use has not been established.
Mylan Launches Generic Version of Tecfidera for MS
This is the first FDA-approved therapeutically equivalent, substitutable generic of Tecfidera.
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