Neurology News Alerts

• Alert FDA OKs Augmented Reality GLOW800 Vascular Fluorescence Newly approved GLOW800 provides surgeons with a 'complete view of anatomy and physiology during vascular neurosurgery, the company says.
  FDA Approvals, September 2018
• Alert FDA Reaffirms Safety of Pimavanserin in PD Psychosis The agency's postmarket review finds no new or unexpected safety risks associated with the antipsychotic, but some prescribing patterns are 'potentially concerning.'
  News Alerts, September 2018
• Alert FDA Approves Fremanezumab (Ajovy) for Migraine Prevention The FDA has approved a second calcitonin-gene-related peptide antagonist for the prevention of migraine in adults.
  FDA Approvals, September 2018
• Alert FDA Clears Liquid Riluzole (Tiglutik) for ALS An oral suspension formulation of riluzole may help overcome challenges of disease-related dysphagia in patients with ALS.
  FDA Approvals, September 2018
• Alert EC Approves Rivaroxaban Plus Aspirin Regimen for CAD, PAD The rivaroxaban/aspirin combination is for the prevention of thrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease at high risk for ischemic events.
  International Approvals, August 2018
• Alert FDA Clears 3-Minute Brain Stimulation Protocol for Depression MagVenture's intermittent theta-burst stimulation system reduces treatment time per session from 37 minutes to 3 minutes.
  FDA Approvals, August 2018
• Alert FDA Okays Stiripentol (Diacomit) for Dravet Syndrome Stiripentol is indicated for patients aged 2 years or older who are also taking clobazam.
  FDA Approvals, August 2018
• Alert FDA Clears Brain Stimulation Device for OCD The Brainsway deep transcranial magnetic stimulation system is an option for patients with obsessive-compulsive disorder (OCD) who have not responded to traditional treatments.
  FDA Approvals, August 2018
• Alert FDA Clears New Spinal Implant The Foundation 3D anterior lumbar interbody cage implant uses CoreLink's proprietary mimetic metal technology, which mimics key characteristics of natural bone.
  FDA Approvals, August 2018
• Alert FDA Clears Peripheral Nerve Stimulator for Pain Management The system is the only percutaneous PNS system cleared by the FDA and is indicated for up to 60 days in the back and/or extremities for both chronic and acute pain.
  FDA Approvals, August 2018
• Alert First Biomarker Evidence Autism Is Linked to DDT A large study provides the first biomarker evidence that maternal exposure to the pesticide DDT may raise the risk for autism in offspring.
  News Alerts, August 2018
• Alert FDA Approves First Oral Drug for Fabry Disease Migalastat (Galafold) is for adults with Fabry disease who have a genetic mutation amenable to treatment based on laboratory data.
  FDA Approvals, August 2018
• Alert FDA OKs Patisiran (Onpattro) for Polyneuropathy in hAATR Patisiran is the first FDA-approved treatment for polyneuropathy caused by hATTR and the first RNA-based therapy to treat a rare disease.
  FDA Approvals, August 2018
• Alert FDA Turns Down Abuse-Deterrent Remoxy ER for Pain The FDA has followed its Advisory Committee's earlier recommendation and nixed approval of abuse-deterrent oxycodone extended-release capsules (Remoxy ER) for severe pain.
  FDA Approvals, August 2018
• Alert Wireless Upgrade to Abbott's DBS System Makes It MRI-Compatible The FDA has cleared a wireless software upgrade for all currently implanted Infinity DBS systems for Parkinson’s and essential tremor that delivers MRI-conditional labeling.
  FDA Approvals, August 2018
• Alert FDA Approves Azedra for Rare Neuroendocrine Tumors The radioactive systemic agent or radiopharmaceutical is administered by intravenous injection and is the first FDA-approved drug in this setting.
  FDA Approvals, July 2018
• Alert FDA Nixes Approval of Buprenorphine Spray for Pain Today the FDA turned down approval of Buvaya, a buprenorphine sublingual spray for moderate to severe pain because of reported safety concerns.
  News Alerts, July 2018
• Alert Synthetic Pot Laced With Rat Poison a Risk to US Blood Supply The US Food and Drug Administration warns that synthetic cannabis laced with rat poison poses a significant health risk to users and the US blood supply.
  News Alerts, July 2018
• Alert Deaths From Fentanyl, Fentanyl Analogs Have Risen Sharply Deaths from fentanyl and fentanyl analogs, such as carfentanil, have more than doubled since 2015, the CDC reports. The increase is a result of increased supply of the drugs and their mixture with heroin.
  News Alerts, July 2018
• Alert The Best Children's Hospitals, According to US News For the fifth consecutive year, Boston Children's Hospital is ranked number 1 by US News & World Report.
  Medscape Medical News, June 2018