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Ceribell
NEWS

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 injuryClarity algorithm allows seizure detection in both pediatric &…
April 17, 2025

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Disease of the Month – Lennox-Gastaut syndrome (LGS)
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…
March 26, 2025

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GRIN Therapeutic
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.…
February 27, 2025

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Disease of the Month – Epilepsy
INSIGHTS+

Disease of the Month – Epilepsy

Shots: Epilepsy is a chronic, non-communicable brain condition that affects neurons and causes recurring seizuresOur 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 epilepsyFor a detailed analysis and tailored…
January 21, 2025

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Viewpoints_Bradley Galer
VIEWPOINTS

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…
February 16, 2021

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