Notizie Newsletter
Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts
October 29, 2019 - The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System ...Leggi tutto
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 ...Leggi tutto
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 ...Leggi tutto
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 ...Leggi tutto
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 ...Leggi tutto