CLINICAL ROLE -
Acute Migraine Treatment Gets FDA Complete Response Letter
Rizaport is an oral film formulation of rizatriptan benzoate, the active drug in Maxalt, for patients with migraine who experience dysphagia or migraine-related nausea.
FDA to Evaluate Immunotherapy for Peanut Allergy
Aimmuneâ€™s Biologics License Application for AR101 under evaluation as a treatment to reduce the risk of anaphylaxis in peanut-allergic children and adolescents following exposure to peanut.
Depression in Risk for Acne Patients Not Linked to Isotretinoin
A large retrospective study of patients with acne found no significant association between isotretinoin exposure and depression.
Immunotherapy for Peanut Allergy Shows Positive Outcomes
Continued consumption of peanuts was associated with positive quality of life and perceptions of safety following immunotherapy treatment for peanut allergy.
Psoriasis Patients Without Psoriatic Arthritis Benefit More From Methotrexate
A study of methotrexate in patients with psoriasis found that the immunosuppressive drug was more effective in patients without psoriatic arthritis than those with the added condition.
Cannabis Ointment Shows Promise in Early Trial for Skin Disease
Topical medical grade cannabis ointment found to be safe and tolerable in early trial for skin disease.
Rheumatoid Arthritis Biosimilar Meets Equivalency Endpoints in Phase 1/3 Trial
Rituximab is approved by the FDA for the treatment of adults with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
FDA Grants Priority Review to Drug for Spinal Muscular Atrophy
Onasemnogene abeparvovec (Zolgensma) is a 1-time infusion that replaces the defective or missing SMN1 gene with a functional copy.
FDA Officials OK Dextenza for Post-Ophthalmic Surgery Pain Management
Safety data came from both phase 3 studies as well as a phase 2 study of Dextenza, which together totaled 351 patients.
FDA Accepts BLA for Spinal Muscular Atrophy Drug
Abeparvovec (Zolgensma) is a one-time infusion that replaces the defective or missing SMN1 gene with a functional copy that can create the SMN protein and prevent the loss of motor neurons in patients with spinal muscular atrophy.
Fingolimod Shows Superior Results in Reducing Multiple Sclerosis Relapses
Fingolimod (Gilenya) found to significantly reduce the annualized relapse rate compared with glatiramer acetate among patients with relapsing-remitting multiple sclerosis.
New Data Show Early Initiation of Ocrelizumab Improves MS Outcomes
New 5-year data from phase 3 studies show that patients treated earlier with ocrelizumab (Ocrevus) had better outcomes on multiple measures of multiple sclerosis disease activity.
NDA Filed for Secondary Progressive Multiple Sclerosis Treatment
Siponimod is an oral, once-daily medication for the treatment of multiple sclerosis in adults.
Increase in US Midlife Mortality Points to Deeper Issues
Growth in midlife mortality includes conditions such as heart disease, liver cancer, pulmonary disease, obesity, and neurologic disorders.
FDA Approves First Treatment for Rare Eye Disease
The FDA approved cenegermin (Oxervate), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea.
US Opioid Prescriptions Remain Unchanged
Newly published research shows that from 2007 to 2016 opioid prescriptions have remained relatively unchanged, despite the growing awareness of potential dangers of opioid abuse.
Investigational Antiviral Flu Drug Achieves Efficacy Goal in Phase 3 Trial
The phase 3 CAPSTONE-2 study of the safety and efficacy of baloxavir marboxil in patients at high risk of complications due to influenza (flu) has met the primary objective of efficacy of a single dose of baloxavir marboxil compared to placebo.
MS Drug Delays Wheelchair Need for Patients with Progressive Multiple Sclerosis
Phase 3 data show that ocrelizumab (Ocrevus) may delay the progression of disability, such as the need for a wheelchair, in patients with primary progressive multiple sclerosis (PPMS).
Updated Secukinumab Label to Include Evidence for Treatment of Psoriatic Arthritis
The updated label includes new evidence that the treatment significantly impedes the progression of joint structural damage at 24 weeks compared to placebo for patients with active psoriatic arthritis.
FDA OKs Secukinumab Label Update for Psoriatic Arthritis
The label update includes new evidence that the treatment significantly impedes the progression of joint structural damage at 24 weeks compared to placebo for patients with active psoriatic arthritis.
FDA OKs Neurostimulation Device for Opioid Withdrawal
DyAnsys Inc. announced that its auricular neurostimulation device, Drug Relief, received clearance from the FDA.
Migraine Preventive Treatment Meets Primary Endpoint in Trial
Allergan announced positive topline results from CGP-MD-01, a phase 2b/3 clinical trial of atogepant.
FDA Grants Emicizumab Priority Review for Hemophilia A
Emicizumab-kxwh is an antibody that activates the natural coagulation process in people with hemophilia A who lack factor VIII.
FDA Accepts NDA for Investigational Type 1 Diabetes Oral Drug
Sanofi announced that the FDA has accepted the New Drug Application (NDA) for Zynquista (sotagliflozin).
Drug for Rare Form of Rickets Gets FDA Approval
Burosumab (Crysvita, Ultragenyx) is the first treatment approved for x-linked hypophosphatemia in adults and children ages 1 and older.
Gene Therapy Shows Promise Treating Spinal Muscular Atrophy
AVXS-101 gene therapy for the treatment of children with spinal muscular atrophy type 1 showed remarkable progress, especially for children treated at less than 3 months of age.
Monoclonal Antibody Reduces Monthly Migraine Headache Days
Galcanezumab shows a significant reduction in monthly migraine days in treatment-resistant patients.
FDA OKs Burosumab for Rare Form of Rickets
The serious condition leaves children with bowed legs, short stature, and bone and dental pain.
FDA Approves Femoral Venous Closure Devices
The ProGlide delivers a single suture to close puncture sites in the femoral vein or artery following a catheterization procedure.
Overdose Deaths Spike from Synthetic Opioids
Drug overdoses killed 63,632 Americans in 2016 and nearly 66% of those deaths involved a prescription or illicit opioid.
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