FDA Approves Spinal Cord Stimulation Therapy for Painful Diabetic Neuropathy
The FDA has approved the Senza® Omnia spinal cord stimulation system for the treatment of chronic pain associated with PDN.
All articles by Brian Park, PharmD
FDA Clears Wearable, Wireless Thermometer for Prescription, OTC Use
The FDA has granted 510(k) clearance to Radius Tº, a wearable, wireless thermometer to measure body temperature for both prescription and over-the-counter use in individuals 5 years of age and older.
FDA: More Data Needed to Support Arimoclomol in Niemann-Pick Disease Type C
Arimoclomol is an investigational oral drug candidate that is designed to amplify and sustain the cellular production of heat shock proteins.
Aduhelm Label Update Clarifies Patient Population Studied in Trials
The treatment, which is administered as a monthly intravenous infusion, binds to aggregated β-amyloid and promotes removal of amyloid from the brain.
Lenacapavir NDA Submitted for HIV-1 in Heavily Treatment Experienced Patients
Lenacapavir is an investigational, long-acting HIV-1 capsid inhibitor designed to inhibit HIV replication at multiple stages of its lifecycle.
Adhansia XR Labeling Updated With Additional Clinical Data
The sNDA approval was based on data from a phase 3 Adult Laboratory Classroom study that assessed the efficacy and safety of Adhansia XR in adults diagnosed with ADHD.
Gene Therapy Candidate Fast Tracked for GM1 Gangliosidosis
LYS-GM101 is a gene therapy designed to replace the gene mutation and restore the production of the beta-galactosidase enzyme.
FDA to Review Vutrisiran 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.
Study Compares Remote Electrical Neuromodulation to Migraine Medications in Adolescents
Nerivio is a wireless remote electrical neuromodulation device approved for the acute treatment of episodic or chronic migraine in patients 12 years of age and older.
Exservan Now Available for Amyotrophic Lateral Sclerosis
According to the CDC, more than a thousand cases of myocarditis and pericarditis following mRNA COVID-19 vaccination have been reported to the Vaccine Adverse Event Reporting System since April 2021.
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