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Notizie AIOM – anno XVII

31 Ottobre 2019

Statement on FDA’s new report regarding root causes and potential solutions to drug shortages

October 29, 2019 - One of the U.S. Food and Drug Administration’s top priorities is to ensure that Americans have access to safe and effective medicines. Sometimes, for a number of reasons, shortages of certain medicines occur and the FDA works immediately with our ...
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28 Ottobre 2019

Advances in Small Bowel Cancer Generate New NCCN Guidelines

Oct 20, 2019 - A new set of recommendations for the treatment of small bowel adenocarcinoma (SBA), a relatively rare type cancer of the gastrointestinal (GI) tract, have been created by the National Comprehensive Cancer Network (NCCN). The guidelines are the first in the ...
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28 Ottobre 2019

FDA Approves Single-Dose Aprepitant Regimen for MEC

October 22, 2019 - The FDA has expanded the approval of aprepitant injectable emulsion for intravenous (IV) use to include the 130-mg single-dose regimen for patients receiving moderately epigenetic chemotherapy (MEC). The label expansion standardizes the aprepitant 130 ...
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28 Ottobre 2019

FDA Approves Niraparib for HRD+ Advanced Ovarian Cancer

October 23, 2019 - The FDA has approved niraparib for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 prior chemotherapy regimens, and whose cancer is associated with homologous recombination ...
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28 Ottobre 2019

Statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants

October 23, 2019 - The U.S. Food and Drug Administration is taking another significant step in protecting women’s health by helping to ensure patients have complete information about the benefits and risks of breast implants. In a draft guidance issued today, we are ...
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28 Ottobre 2019

Eflapegrastim Application Resubmitted to FDA for Chemo-Induced Neutropenia

October 25, 2019 - An updated biologics license application (BLA) has been submitted to the FDA for eflapegrastim for the management of chemotherapy-induced neutropenia, according to Spectrum Pharmaceuticals, the developer of the novel long-acting granulocyte-colony stimulating ...
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28 Ottobre 2019

Comparison of PARPis with Angiogenesis Inhibitors and Chemotherapy for Maintenance in Ovarian Cancer: A Network Meta-Analysis

Seventy-five percent of ovarian cancer would relapse within 18-28 months after platinum-base chemotherapy. Evidence suggests that maintenance chemotherapy is effective in prolonging remission. Recent target therapies such as poly(ADP-ribose) polymerase inhibitors (PARPis) ...
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28 Ottobre 2019

Statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products

October 24, 2019 - The U.S. Food and Drug Administration (FDA) recognizes that consumers may use various types of unapproved drugs, such as homeopathic drug products, to treat or relieve different diseases and conditions. These products are often marketed as natural alternatives ...
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28 Ottobre 2019

Enhancing consistency in wording of therapeutic indications to support healthcare decision-making

October 21, 2019 - EMA’s human medicines committee (CHMP) has developed a paper to strengthen consistency when defining therapeutic indications in the product information of medicines. The document is intended to guide assessors in the national competent authorities ...
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28 Ottobre 2019

European Commission Approves 4-Week Nivolumab Dosing Schedule in Adjuvant Melanoma

October 24, 2019 - The European Commission has approved nivolumab at a flat dosing schedule of either 240 mg over 30 minutes every 2 weeks, or 480 mg infused over 60 minutes every 4 weeks, for the adjuvant treatment of patients with melanoma who have involvement of lymph ...
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