Tag : united states food and drug administration

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FDA Clears Ozanimod (Zeposia) for MS; COVID-19 Delays Launch

Newsemia
Ozanimod is the first oral, once-daily sphingosine-1-phosphate receptor modulator approved for adults with relapsing forms of multiple sclerosis. Source link...
Neurology

COVID-19 Prompts 'Lifesaving' Policy Change for Opioid Addiction

Newsemia
In the face of COVID-19, SAMHSA has announced policy changes that will allow some patients in treatment for opioid use disorder to receive a 28-day...
Latest News

COVID-19 Prompts 'Lifesaving' Policy Change for Opioid Addiction

Newsemia
In the face of COVID-19, SAMHSA has announced policy changes that will allow some patients in treatment for opioid use disorder to receive a 28-day...
Neurology

FDA Adds Boxed Warning to Montelukast Over Mental Health Risks

Newsemia
With ongoing reports of serious neuropsychiatric side effects, the agency advises that healthcare providers avoid prescribing montelukast for patients with mild symptoms, particularly those with...
Neurology

FDA Bans Electrical Stimulation Devices for Behavior Control

Newsemia
The US FDA has banned electrical stimulation devices used to control self-injurious or aggressive behavior, saying they represent an ‘unreasonable and substantial’ risk for illness...
Neurology

FDA OKs First Once-Daily IV COX-2 Preferential NSAID for Pain

Newsemia
The FDA approved meloxicam injection (Anjeso, Baudax Bio) for the treatment of moderate to severe pain, either by itself or with other NSAID analgesics. FDA...
Neurology

Suicidal Patients Often Excluded From Antidepressant Trials

Newsemia
Clinical trials of antidepressants that inform FDA approval decisions often exclude suicidal patients, leaving clinicians uncertain of the efficacy of these drugs in this patient...
Neurology

Are FDA Panel Votes on Psych Drugs Tainted by Speakers' COIs?

Newsemia
Members of the public who receive expenses from pharmaceutical study sponsors to attend FDA advisory panel meetings to testify about new psychiatric drugs are highly...
Neurology

Maybe Memorizing the Krebs Cycle Was Worthwhile After All

Newsemia
Mitochondrial disorders are often difficult to diagnose and treat due to their multisystem nature. As scientists better understand mitochondrial function, effective treatments are beginning to...
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

Newsemia
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...

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