CLINICAL ROLE -
Amantadine Gains FDA Approval for Parkinson's Disease
Amantadine previously received FDA approval for antiviral and antiparkinsonian treatment.
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Levetiracetam Shows Superiority to Other Pediatric Epilepsy Drug
Oral anticonvulsant therapy significantly reduces seizure rates compared with phenobarbital.
Lung Resection Associated With Opioid Addiction
Patients who undergo lung resection surgery found to become persistent opioid users in the months following their procedure.
Migraine Pain Therapy Gets FDA Approval
Non-invasive nerve stimulation device approved for the treatment of pain associated with migraines in adult patients.
Oculopharyngeal Muscular Dystrophy Drug Granted Orphan Designation by FDA
Therapy silences the expression of the mutant gene associated with OPMD, while also restoring normal gene function.
Trial to Compare Cosentyx With Adalimumab Biosimilar in Ankylosing Spondylitis
Landmark trial to evaluate the superiority of secukinumab for slowing spinal bone damage versus proposed biosimilar adalimumab.
Severe Aplastic Anemia Drug Gets Breakthrough Designation
Promacta is a bone marrow stimulant previously approved by the FDA to treat adults and children with chronic immune thrombocytopenia.
Monthly Monoclonal Antibody Effective Treating Migraine Headaches
Galcanezumab shows efficacy, safety, and tolerability for the preventive treatment of migraines.
FDA Seeks to Facilitate Greater Use of Generic Drugs
The FDA has published an update to its list of off-patent, off-exclusivity drugs without any approved generics.
Medical Cannabis May Improve Neurocognitive Disorder in Patients With HIV
THC found to slow the process of neurodegeneration, which affects nearly half of all patients with HIV.
FDA to Evaluate Expanded Indication for COPD Drug
Trelegy Ellipta is a combination of an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist for chronic obstructive pulmonary disease.
Novel Tear Neurostimulator May Improve Dry Eye Symptoms
llergan’s TrueTear Intranasal Tear Neurostimulator was granted marketing authorization by the FDA in April.
FDA to Evaluate Mepolizumab for COPD
Nucala is an interleukin-5 antagonist under consideration as an add-on maintenance therapy for certain patients with chronic obstructive pulmonary disease.
Dupixent Shows Consistent Efficacy Treating Asthma Attacks
Dupilumab is a monoclonal antibody previously approved to treat moderate-to-severe atopic dermatitis.
Generic Drug Approvals Continue to Surge
The FDA approved 763 generic drugs in the 2017 fiscal year, which is the highest annual rate since the administration began recording the data.
FDA Grants Dyskinesia Treatment Orphan Drug Designation
Gocovri is the only FDA-approved therapy for dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy.
Generalized Myasthenia Gravis Treatment Approved by FDA
Soliris treats paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Alzheimer's Disease Drug Fast Tracked by FDA
A novel, oral anti-amyloid optimized prodrug of tramiprosate has a novel mechanism that blocks an agent of Alzheimer’s disease development and progression.
FDA Halts Crohn's Disease Trial
The FDA a stop to Celgene’s REVOLVE trial and extension trial for GED-0301 (mongersen), an oral compound currently not approved for any uses.
Tardive Dyskinesia Treatment Market Continues to Grow
Valbenazine (Ingrezza) was the first approved treatment for the antipsychotic medication-induced movement disorder.
Biologic Drug Under Evaluation to Treat Chronic Inflammatory Esophagus
The monoclonal antibody dupilumab may be effective treating active moderate-to-severe eosinophilic esophagitis.
FDA Supports Approval of Gene Therapy for Inherited Retinal Disease
Voretigene neparvovec (Luxturna) treats biallelic RPE65-mediated inherited retinal disease.
Has the Hepatitis C Treatment Well Run Dry?
National brand spending and new patient rates for hepatitis C virus dropped last year.
New Zika Blood Test Gains FDA Approval
Qualitative nucleic acid test is designed to detect Zika virus RNA in individual donor plasma specimens.
FDA Approves Generic Multiple Sclerosis Drug
Two different Copaxone injection doses approved for relapsing forms of multiple sclerosis.
Progress Continues in New Multiple Sclerosis Drugs
New classes of multiple sclerosis medications are improving on disease suppression.
FDA Warns of Deaths Linked to Primary Biliary Cholangitis Drug
Obeticholic acid (Ocaliva) for primary biliary cholangitis has been tied to 30 severe liver damage cases.
Editing Stem Cells Could Lead to New Rheumatoid Arthritis Drug
Altered stem cells are capable of developing into cartilage cells that create a biologic anti-inflammatory drug.