Zeposia (ozanimod) is an oral sphingosine-1 phosphate (S1P) receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Emerging Technology Reports
The Emerging Technology Report provides regular updates about emerging and potentially disruptive technologies that are likely to have a significant impact in healthcare. This “early warning” report monitors new health technologies from 6 months to 2 years within a regulatory submission and tracks those as they go through clinical trial development and the regulatory approval process.
For each emerging technology, our analysts describe the technology and intended use, its prospects relative to the regulatory process and FDA information, competing technologies, relevant clinical guidelines, high-level look at the evidence such as published abstracts in the medical literature and available meeting abstracts, and available clinical trials.
Ayvakit (Avapritinib) for Gastrointestinal Stromal Tumor
Ayvakit (avapritinib) is an oral potent and selective inhibitor of activated KIT and PDGFRA mutant kinases, particularly activation loop mutations and highly resistant PDGFRA D842V mutation. It is indicated for the treatment of adults with unresectable or metastatic gastrointestinal s…
Vazegepant for Acute Treatment of Migraine
Vazegepant is an intranasal novel small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist (“gepant”) drug proposed for the acute treatment of migraine headache. CGRP is involved in vasodilation and sensory transmission and is a validated target for the treatment of migraine headache.
Nerivio Migra for Acute Treatment of Migraine
Nerivio Migra provides neuromodulation therapy through a noninvasive, wearable device. It is indicated for the acute treatment of migraine headache in adults who do not have chronic migraine. The Nerivio Migra system consists of a pair of electrodes mounted on an armband with a power source. The wireless device is self-applied to the upper arm and delivers transcutaneous elec…
Risdiplam for Spinal Muscular Atrophy
Risdiplam (formerly RG7916) is an investigational, oral small molecule SMN2-splicing modifier designed to help the survival motor neuron 2 (SMN2) gene produce more SMN protein. It is in development for the treatment of spinal muscular atrophy (SMA).
Nerivio Migra for Acute Treatment of Migraine
Nerivio Migra provides neuromodulation therapy through a noninvasive, wearable device. It is indicated for the acute treatment of migraine headache in adults who do not have chronic migraine. The Nerivio Migra system consists of a pair of electrodes mounted on an armband with a power source. The wireless device is self-applied to the upper arm and delivers transcutaneous elec…
WavelinQ (formerly EverlinQ) EndoAVF System
The WavelinQ endoAVF system is a catheter-based system for the endovascular creation of an arteriovenous fistula (AVF) in patients requiring hemodialysis. The system consists of a pair of over-the-wire catheters with magnets arranged to pull them into alignment and opposition. The venous catheter contains a spring-loaded radiofrequency (RF) electrode, and the arterial cathete…
WavelinQ (formerly EverlinQ) EndoAVF System
The WavelinQ endoAVF system is a catheter-based system for the endovascular creation of an arteriovenous fistula (AVF) in patients requiring hemodialysis. The system consists of a pair of over-the-wire catheters with magnets arranged to pull them into alignment and opposition. The venous catheter contains a spring-loaded radiofrequency (RF) electrode, and the arterial cathete…
Monarch eTNS for Attention-Deficit/Hyperactivity Disorder
The Monarch eTNS is an external trigeminal nerve stimulator for the treatment of attention-deficit/ hyperactivity disorder (ADHD) in children aged 7 to 12 years who are not currently taking prescription ADHD medication.
Monarch eTNS for Attention-Deficit/Hyperactivity Disorder
The Monarch eTNS is an external trigeminal nerve stimulator for the treatment of attention-deficit/ hyperactivity disorder (ADHD) in children aged 7 to 12 years who are not currently taking prescription ADHD medication.