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Nirsevimab-alip, marketed as Beyfortus by AstraZeneca, has received US Food and Drug Administration authorization for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in infants and children up to 2 years old.
Norgestrel birth control tablets—marketed as Opill by Laboratoire HRA Pharma, which was acquired by Perrigo Company plc—recently received US Food and Drug Administration (FDA) approval for nonprescription use to prevent pregnancy, the agency announced in a statement. The progestin-only pills, which were first approved in 1973 for prescription use, will be available for over-the-counter purchase at drug and convenience stores as well as online starting in 2024, according to a release from the manufacturer.
Lecanemab-irmb, marketed by Eisai Inc as Leqembi, has been converted to traditional approval after receiving accelerated approval in January, the US Food and Drug Administration (FDA) announced. The drug, which reduces the condition’s characteristic amyloid plaques in the brain, can be used to treat Alzheimer disease.
Objectives
This study aimed to conduct a thorough analysis of fluid retention-associated adverse events (AEs) associated with BCR::ABL inhibitors.
Design
A retrospective pharmacovigilance study.
Setting
Food and Drug Administration Adverse Event Reporting System (FAERS) database for BCR::ABL inhibitors was searched from 1 January 2004 to 30 September 2021.
Main outcome measures
Reporting OR (ROR) and 95% CI were used to detect the signals. ROR was calculated by dividing the odds of fluid retention event reporting for the target drug by the odds of fluid retention event reporting for all other drugs. The signal was considered positive if the lower limit of 95% CI of ROR was >1. The analysis was run only considering coupled fluid retention events/BCR::ABL inhibitors with at least three cases.
Results
A total of 97 823 reports were identified in FAERS. Imatinib had the most fluid retention signals, followed by dasatinib and nilotinib, while bosutinib and ponatinib had fewer signals. Periorbital oedema (ROR=24.931, 95% CI 22.404 to 27.743), chylothorax (ROR=161.427, 95% CI 125.835 to 207.085), nipple swelling (ROR=48.796, 95% CI 26.270 to 90.636), chylothorax (ROR=35.798, 95% CI 14.791 to 86.642) and gallbladder oedema (ROR=77.996, 95% CI 38.286 to 158.893) were the strongest signals detected for imatinib, dasatinib, nilotinib, bosutinib and ponatinib, respectively. Pleural effusion, pericardial effusion and pulmonary oedema were detected for all BCR::ABL inhibitors, with dasatinib having the highest RORs for pleural effusion (ROR=37.424, 95% CI 35.715 to 39.216), pericardial effusion (ROR=14.146, 95% CI 12.649 to 15.819) and pulmonary oedema (ROR=11.217, 95% CI 10.303 to 12.213). Patients aged ≥65 years using dasatinib, imatinib, nilotinib or bosutinib had higher RORs for pleural effusion, pericardial effusion and pulmonary oedema. Patients aged ≥65 years and females using imatinib had higher RORs for periorbital oedema, generalised oedema and face oedema.
Conclusions
This pharmacovigilance study serves as a clinical reminder to physicians to be more vigilant for fluid retention-associated AEs with BCR::ABL inhibitors.
Chi ha superato la malattia non sarà discriminato per mutui e adozioni. Il testo va ora in Senato
Istituto Analisi delle politiche pubbliche, 9 su 10 sono insoddisfatti
Istituto Analisi delle politiche pubbliche, 9 su 10 sono insoddisfatti
The US Food and Drug Administration (FDA) recently approved donislecel, marketed by CellTrans Inc as Lantidra, for the treatment of type 1 diabetes in adults who experience repeated episodes of severe low blood glucose levels. The treatment involves the infusion of insulin-producing pancreatic islet beta cells from deceased donors into patients’ hepatic portal veins and immunosuppressive medication to maintain islet cell viability.
This study assesses the frequency of continuation patents on brand-name drugs approved by the US Food and Drug Administration from 2000 to 2015.
Al via una sperimentazione all’Irccs Santa Lucia
Empagliflozin, a sodium-glucose cotransporter 2 inhibitor that lowers blood glucose levels by increasing the amount excreted in urine, was recently approved by the US Food and Drug Administration (FDA) for the management of type 2 diabetes in children 10 years or older. The drug—marketed as Jardiance when administered alone and as Synjardy when combined with metformin—has already been approved for adults with type 2 diabetes. It is taken by mouth and can be used in addition to dietary changes and exercise to improve blood glucose levels, the FDA said in a statement. The approval is based on results from a randomized clinical trial involving 158 participants.
New draft guidance from the US Food and Drug Administration (FDA) includes a series of considerations for researchers designing clinical trials to investigate “classic psychedelics,” such as psilocybin, lysergic acid diethylamide (known as LSD), and methylenedioxymethamphetamine (known as MDMA). Psychedelics, many of which are currently classified as Schedule I controlled substances, have shown promise in recent years for the treatment of medical conditions such as depression, posttraumatic stress disorder, and substance use disorders, according to the FDA’s statement.
E-cigarette sales increased by about 47% between 2020 and 2022, according to an analysis of retail data by the US Centers for Disease Control and Prevention (CDC). Sales of disposable devices in flavors such as fruit, chocolate, and candy increased after the US Food and Drug Administration (FDA) announced in 2020 that it would begin enforcing restrictions on prefilled flavored e-cigarettes. Top-selling brands at the end of the study period included Elf Bar, a popular disposable e-cigarette brand among US teens aged 16 to 19 years.
Circulation, Volume 148, Issue 4, Page 309-311, July 25, 2023.
Comunicato del 10/07/2023 n°37
Non solo cibi sani ma anche in quantità moderate e associati
