domenica, 8 settembre 2024

Notizie AIOM – anno XVI n. 680

19 giugno 2018 – Registri AIFA: l’Agenzia fornisce informazioni sui dati dei trattamenti con i nuovi farmaci per la cura dell’epatite C

15 giugno 2018 – EMA. Consultazione pubblica su un concept paper per la revisione delle Linee guida sulla valutazione dei medicinali per le infezioni batteriche

Immunotherapy Now Standard for Some Patients With CRC

With recent approvals of pembrolizumab and nivolumab for the treatment of refractory deficient mismatch repair (dMMR) metastatic colorectal cancer (CRC), immunotherapy has made its way into the field of gastrointestinal oncology. Many questions remain, however, including ...
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Plasma Cell-Free DNA May Offer Noninvasive Method for Lung Cancer Screening

Comprehensive sequencing of plasma cell-free DNA (cfDNA) demonstrates the ability to noninvasively detect lung cancer with reliable specificity and sensitivity, according to preliminary data from the Circulating Cell-free Genome Atlas (CCGA) study presented during the “Lung ...
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Expanding the Uses of Cell-Free DNA Assays: From Guiding Treatment Decisions to Applications in Early Disease Detection

Analyzing cell-free DNA (cfDNA) circulating in plasma or serum can help oncologists determine the genotype of tumors noninvasively to guide treatment decisions and may eventually allow them to monitor treatment response, predict recurrence, and screen for cancer. cfDNA is ...
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FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence

June 14, 2018 - The U.S. Food and Drug Administration today approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. “The FDA is taking new steps to advance the development ...
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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food

June 14, 2018 - Increasingly, Americans are seeking healthy food options, whether they’re eating out or dining at home. Their ability to choose healthy foods starts with their ability to understand what’s in their food in the first place. Public surveys suggest ...
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Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making

June 12, 2018 - Over the past decade, advances in our understanding of the basic biology of serious and life-threatening diseases has led to the development and FDA approval of targeted treatments for patients with a specific molecular sub-type. These more targeted treatments ...
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Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

June 7, 2018 - We’re encouraged by declines in overall youth tobacco use over the last several years reflected in the 2017 National Youth Tobacco Survey. Protecting our nation’s youth from the dangers of tobacco products is among the U.S. Food and Drug Administration’s ...
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Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

June 13, 2018 - This concept paper proposes the development of a single guideline on the clinical evaluation of medicinal products indicated for treatment of bacterial infections. The development of this single guideline is intended to merge, revise and add to the guidance ...
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