New Drugs

  • FDA approves first treatment for metastatic Merkel cell carcinoma

    on March 24th, 2017
    The Food and Drug Administration has granted accelerated approval to avelumab for the treatment of metastatic Merkel cell carcinoma (MCC) in adult and pediatric patients aged 12 years and older. Avelumab, a programmed death-ligand 1 (PD-L1)–blocking human IgG1 lambda monoclonal antibody, is the fi[...]
  • Novel antifungal had favorable safety, efficacy profile for onychomycosis in phase IIB study

    on March 23rd, 2017
    AT AAD 17 ORLANDO (FRONTLINE MEDICAL NEWS) – A novel orally administered antifungal showed a favorable safety and efficacy profile in the treatment of distal lateral subungual onychomycosis, in a phase IIB study presented at the annual meeting of the American Academy of Dermatology. In the RENOVAT[...]
  • FDA approves safinamide to treat Parkinson’s disease

    on March 22nd, 2017
    The U.S. Food and Drug Administration approved safinamide tablets on March 21 as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. Newron Pharmaceuticals will market safinamide under the brand name Xadago. Par[...]
  • Immunotherapy boosts OS from metastatic cervical cancer in early trial

    on March 15th, 2017
    AT THE ANNUAL MEETING ON WOMEN’S CANCER NATIONAL HARBOR, MD – An investigational targeted immunotherapy led to a 52% improvement in overall survival, compared with pooled historical data, among patients with previously treated metastatic cervical cancer. Patients in the phase II trial who receiv[...]
  • FDA approves ribociclib for HR+, HER2– advanced breast cancer

    on March 14th, 2017
    The Food and Drug Administration has approved ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor[...]
  • FDA committee approves strains for 2017-2018 flu shot

    on March 13th, 2017
    At AN FDA ADVISORY COMMITTEE MEETING ROCKVILLE, MD. (FRONTLINE MEDICAL NEWS) – A committee of Food and Drug Administration advisers backed the World Health Organization’s influenza vaccine recommendations for the 2017-2018 season at a meeting March 9. In a unanimous vote, members of the Vaccines[...]
  • CORRECTION: New 52-week EASI, pruritus data strengthen case for dupilumab in adult atopic dermatitis

    on March 10th, 2017
    In an article titled “New 52-week EASI, pruritus data strengthen case for dupilumab in adult atopic dermatitis,” published March 9, 2017, the rates of clear or almost clear skin were misstated. The Investigator Global Assessment for clear or almost clear skin were 0 or 1.[...]
  • New 52-week EASI, pruritus data strengthen case for dupilumab in adult atopic dermatitis

    on March 9th, 2017
    AT AAD 2017 ORLANDO (FRONTLINE MEDICAL NEWS) – Treatment with dupilumab was associated with significantly improved measures of disease severity, including in quality of life and pruritus symptoms, at 16 and 52 weeks in adults with moderate to severe atopic dermatitis (AD) in the phase III CHRONOS [...]
  • FDA approves first dedicated bifurcation device to treat coronary bifurcation lesions

    on March 8th, 2017
    Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S. In a post hoc an[...]
  • Biosimilars: No big dollar savings, but are clinically ‘dead on’

    on March 7th, 2017
    EXPERT ANALYSIS FROM THE WINTER RHEUMATOLOGY SYMPOSIUM SNOWMASS, COLO. (FRONTLINE MEDICAL NEWS) – If you thought biosimilars would bring sharply reduced pricing compared with their parent agents, with resultant greater patient access to highly effective therapies for rheumatic diseases … thi[...]
  • Voclosporin linked to threefold increase in lupus nephritis remission

    on March 6th, 2017
    Treatment with the investigational calcineurin inhibitor voclosporin is associated with a significant, threefold-higher rate of complete remission for lupus nephritis, compared with the current standard of care, according to 48-week data from the AURA-LV (Aurinia Urinary Protein Reduction Active–L[...]
  • FDA approves sublingual immunotherapy for dust mite allergies

    on March 2nd, 2017
    The Food and Drug administration has approved a sublingual immunotherapy to treat nasal inflammation caused by dust mite allergy. Odactra (Merck, Sharp & Dohme) had been approved in adults aged 18-65 years, with allergic rhinitis with or without conjunctivitis. The tablets offer an alternative t[...]
  • Nemolizumab improves pruritus in atopic dermatitis

    on March 1st, 2017
    FROM THE NEW ENGLAND JOURNAL OF MEDICINE Monthly subcutaneous injections of nemolizumab, a humanized monoclonal antibody that inhibits interleukin-31 signaling, significantly improved pruritus associated with atopic dermatitis (AD) in a small, 3-month phase II trial. The results were published onlin[...]
Back to top