FDA Rejects Pimavanserin sNDA for Dementia-Related Psychosis
The sNDA submission was supported by data from the pivotal phase 3 HARMONY study.
All articles by Brian Park, PharmD
Tongue-Delivered Neuromodulation Therapy Gets FDA Clearance for MS-Related Gait Deficit
PoNS is a portable, noninvasive, prescription-only device intended to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older.
FDA Launches Adverse Event Reporting Dashboard for Authorized COVID-19 Therapeutics
Data will be reported to the FDA by the pharmaceutical industry, health care providers, and consumers.
Zolgensma Benefits Observed in Presymptomatic SMA Patients
The phase 3 SPR1NT trial is an ongoing open-label, single-arm study evaluating onasemnogene in presymptomatic patients (≤6 weeks of age) with a genetic diagnosis of SMA and 2 or 3 copies of survival motor neuron 2 gene.
Dexmedetomidine Oral Film Gets Breakthrough Tx Status for Acute Agitation With Dementia
BXCL501 is an oral thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist.
FDA to Review Efgartigimod for Generalized Myasthenia Gravis
Efgartigimod, an Fc receptor antagonist, reduces disease-causing immunoglobulin G (IgG) antibodies and blocks the IgG recycling process.
FDA Clears Wearable Brain Neuromodulation Device for Acute Migraine
Relivion is worn as a headset delivering stimulation to 6 branches of the occipital and trigeminal nerves through 3 adaptive output channels.
FDA to Review Once-Nightly Sodium Oxybate Formulation for Narcolepsy
The NDA submission is supported by data from the phase 3 REST-ON study.
Tick-Borne Encephalitis Vaccine Gets Priority Review
TicoVac is an inactivated whole virus vaccine developed using a master ‘seed’ virus that is similar to the tick-borne encephalitis virus found in nature.
FDA Clears Vagus Nerve Stimulation Device for Adolescent Migraine
Findings from an adolescent study showed that 46.8% of treated attacks were successfully resolved without the use of any acute rescue medication.
-
Loading...
-
Loading...
Next post in Migraine and Headache
