Tag : united states food and drug administration

Neurology

Levetiracetam Oral Solution Recalled in US

Newsemia
Lannett Company has recalled two lots of the anticonvulsant because of microbial contamination, which was identified during an evaluation of a raw material used to...
Neurology

FDA Okays Cenobamate (Xcopri) for Focal Epilepsy

Newsemia
The FDA has approved cenobamate for seizures in adults with focal epilepsy based on results from two trials of more than 600 patients, as well...
Neurology

SUNFISH: Risdiplam Meets Primary Endpoint in SMA

Newsemia
Risdiplam, an oral investigational agent designed to increase and sustain SMN protein levels of patients with spinal muscular atrophy (SMA), met the primary endpoint in...
Neurology

FDA Approves Botox for Lower-Limb Spasticity in Children

Newsemia
The FDA has approved Botox to ease lower-limb spasticity in children and adolescents aged 2 to 17 years, excluding spasticity caused by cerebral palsy. FDA...
Neurology

FDA Okays Pitolisant (Wakix) for Narcolepsy

Newsemia
The FDA has approved pitolisant, a first-in-class, nonscheduled treatment option with a novel mechanism of action for adults with narcolepsy. FDA Approvals Source link...
Neurology

FDA OKs Botox for Upper Limb Spasticity in Children

Newsemia
Botox is the first neurotoxin to be approved in the US to treat upper limb spasticity for pediatric patients aged 2 years and older. FDA...
Neurology

ORACLE-MS: Cladribine Effective in MS Subgroups

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The recently approved disease-modifying therapy is expected to find a niche for patients with multiple sclerosis who fail other agents. Medscape Medical News Source link...
Neurology

FDA Clears First Soft Robotic Exo-Suit for Stroke Rehab

Newsemia
The ReStore system is designed like a garment that connects to waist pack and cables that help lift the patient’s affected leg in synchronized timing...
Neurology

FDA OKs Dalteparin (Fragmin), First Anticoagulant for Pediatric VTE

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The low-molecular-weight heparin is indicated to reduce the recurrence of symptomatic venous thromboembolism in children as young as 1 month. FDA Approvals Source link...
Neurology

FDA Approves First Vaccine for Dengue, With Restrictions

Newsemia
Dengvaxia is for the prevention of dengue disease caused by all dengue virus serotypes in people aged 9 to 16 years who have previously had...
Neurology

PREVENT: Eculizumab May Lower Relapse Risk in NMOSD

Newsemia
Use of eculizumab resulted in significantly greater relapse reduction over placebo in patients with neuromyelitis optica spectrum disorder (NMSOD), new findings from the phase 3...
Neurology

FDA Warns of Stroke, Death With Off-Label Use of Wingspan Stent

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Postmarket data show a significantly increased risk of stroke or death when the Wingspan intracranial stent system is used outside the approved indications. News Alerts...
Neurology

FDA Okays First Generic Naloxone Nasal Spray for Opioid Overdose

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The FDA has granted final approval for the first generic naloxone hydrochloride nasal spray for reversing or stopping the effects from an opioid overdose. FDA...
Neurology

FDA Clears Intermittent Theta-Burst System for Major Depression

Newsemia
The FDA clearance will let Magstim include intermittent theta-burst stimulation with its Horizon transcranial magnetic stimulation systems for treating major depression, the company announced. Medscape...
Neurology

FDA Confirms Unsafe Levels of Metals in Some Kratom Products

Newsemia
Final laboratory test results support the agency’s public warning about the risk of heavy metals in certain kratom products. News Alerts Source link...

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