Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Shots: The US FDA has granted 510(k) clearance to Clarity algorithm for the detection of electrographic seizures in pts (≥1yrs.) Pediatric clearance was backed by extensive electroencephalography (EEG) dataset developed from ~1,700 pts to detect non-convulsive seizures, ensuring rapid diagnosis & prevention of serious brain injury Clarity algorithm allows seizure detection in both pediatric &…

ByRidhi RastogiApril 17, 2025

News

Neurelis’ Valtoco Receives the US FDA’s Approval for Acute Treatment of Seizure Clusters

Shots: The US FDA has approved Valtoco for short-term treatment of acute repetitive seizures (seizure clusters) in pts (≥2yrs.) with epilepsy Approval was based on P-I/IIa trial assessing safety & PK of Valtoco, which showed favorable safety & efficacy with easy administration in pts who had episodes of frequent seizures; data was presented at CNS…

ByRidhi RastogiApril 17, 2025

INSIGHTS+

Disease of the Month – Lennox-Gastaut syndrome (LGS)

Shots: Lennox-Gastaut syndrome (LGS) is a severe childhood-onset epileptic condition characterized by repeated seizures Our Disease of the Month report covers epidemiology, market size, current management strategies, emerging therapeutic options, and patient advocacy groups involved in enhancing patient care. Additionally, we are highlighting the key industry players advancing treatments for LGS For a detailed epilepsy…

ByDipanshu DixitMarch 26, 2025

News

GRIN Therapeutics Reports the US FDA’s Breakthrough Therapy Designation for Radiprodil to Treat Seizures in GRIN-Related Neurodevelopmental Disorder

Shots: The US FDA has granted BTD to radiprodil for the treatment of seizures in GRIN-related neurodevelopmental disorder harboring GoF mutations Designation was supported by P-Ib (Honeycomb) trial data of radiprodil in pediatric pts, showing 86% decrease in CMS frequency. 71% had >50% CMS reduction, & 6–7 were seizure-free for ≥80% of the 8wk.…

ByRidhi RastogiFebruary 27, 2025

INSIGHTS+

Disease of the Month – Epilepsy

Shots: Epilepsy is a chronic, non-communicable brain condition that affects neurons and causes recurring seizures Our Disease of the Month report covers epidemiology, market size, current management strategies, emerging therapeutic options, and the role of patient advocacy groups. Additionally, we highlight the key industry players advancing treatments for epilepsy For a detailed analysis and tailored…

ByDipanshu DixitJanuary 21, 2025

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PharmaShots Interview: Zogenix’s Bradley Galer Shares Insight on Fintepla (fenfluramine, oral solution)

In an interview with PharmaShots, Bradley Galer, M.D., Chief Medical Officer at Zogenix shed light on data supporting the regulatory application and what the EU approval of Fintepla will mean in terms of reducing the high physical, emotional, and financial burden associated with the disease. Shots: Fintepla was approved by the EC in Dec'2020 as a new add-on therapy to…

BySenior EditorFebruary 16, 2021

Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Neurelis’ Valtoco Receives the US FDA’s Approval for Acute Treatment of Seizure Clusters

Disease of the Month – Lennox-Gastaut syndrome (LGS)

GRIN Therapeutics Reports the US FDA’s Breakthrough Therapy Designation for Radiprodil to Treat Seizures in GRIN-Related Neurodevelopmental Disorder

Disease of the Month – Epilepsy

PharmaShots Interview: Zogenix’s Bradley Galer Shares Insight on Fintepla (fenfluramine, oral solution)

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Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Neurelis’ Valtoco Receives the US FDA’s Approval for Acute Treatment of Seizure Clusters

Disease of the Month – Lennox-Gastaut syndrome (LGS)

GRIN Therapeutics Reports the US FDA’s Breakthrough Therapy Designation for Radiprodil to Treat Seizures in GRIN-Related Neurodevelopmental Disorder

Disease of the Month – Epilepsy

PharmaShots Interview: Zogenix’s Bradley Galer Shares Insight on Fintepla (fenfluramine, oral solution)

FOLLW US

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