Risultati per: La FDA approva il sistema di riabilitazione dell’ictus

The nonhormonal drug fezolinetant is the first of its kind to be approved by the US Food and Drug Administration (FDA) to treat moderate to severe hot flashes—periods of sweating, flushing, and chills—associated with menopause, the agency announced in a statement. Fezolinetant, marketed as Veozah, targets the neurokinin 3 receptor to restore the brain’s regulation of body temperature.

The US Food and Drug Administration (FDA) green-lit the first vaccine against respiratory syncytial virus (RSV). The vaccine, marketed as Arexvy, is approved for people aged 60 years or older, the FDA said in a statement.

Comunicato del 22/05/2023 n°30

Aumento storico del 20% grazie ai contributi fissi degli Stati

People who are aged 65 years or older and have gotten 1 dose of a bivalent COVID-19 vaccine can now receive another at least 4 months after their previous dose, according to a statement by the US Food and Drug Administration (FDA). People who are immunocompromised and have received a bivalent COVID-19 vaccine can also get another after a minimum of 2 months.

Per l’associazione italiana è necessaria più prevenzione

Prepared by isolating firmicutes spores from screened donors, VOWST is currently the only FDA-approved oral FMT option.

Studio su oltre 6 milioni di persone tra i 20 e i 39 anni

Vilobelimab, marketed as Gohibic, has received Emergency Use Authorization from the US Food and Drug Administration (FDA) for patients with severe COVID-19 symptoms. The drug, an anti-C5a monoclonal antibody that targets an inflammatory pathway believed to be involved in COVID-19 progression, is authorized for use in hospitalized patients with COVID-19 within 48 hours of starting invasive mechanical ventilation or extracorporeal membrane oxygenation, according to the FDA announcement.

Objectives
US FDA and EMA allow facilitated regulatory pathways to expedite access to new treatments. Limited supportive data may result in major postapproval variations. In Israel, partly relying on Food and Drug Administration (FDA) and European Medicines Agency (EMA), clinical data are reviewed independently by the Advisory Committee of Drug Registration (ACDR). In this study, the correlation between the number of discussions at the ACDR and major postapproval variations is examined.

Design
This is an observational retrospective comparative cohort study.

Setting
Applications with FDA and/or EMA approval at time of assessment in Israel were included. The timeframe was chosen to allow a minimum of 3 years of postmarketing approval experience for potential major label variations. Data regarding the number of discussions at ACDR were extracted from protocols. Data on postapproval major variations were extracted from the FDA and EMA websites.

Results
Between 2014 and 2016, 226 (176 drugs) applications, met the study criteria. 198 (87.6%) and 28 (12.4%) were approved following single and multiple discussions, respectively. A major postapproval variation was recorded in 129 (65.2%) compared with 23 (82.1%) applications approved following single and multiple discussions, respectively (p=0.002). Increased risk for major variation was found for medicines approved following multiple discussions (HR=1.98, 95% CI: 1.26 to 3.09) with a median time of 1.2 years, applications approved based on phase II trials (HR=2.58, 95% CI: 1.72 to 3.87), surrogate endpoints (HR=1.99, 95% CI: 1.44 to 2.74) and oncologic indications (HR=2.48, 95% CI: 1.78 to 3.45).

Conclusions
Multiple ACDR discussions associated with limited supportive data are predictive for major postapproval variations. Moreover, our findings demonstrate that approval by the FDA and/or EMA does not pave the way to automatic approval in Israel. In a substantial per cent of the cases, submission of the same clinical data resulted in different safety and efficacy considerations, requiring additional supporting data in some cases or even rejection of the application in others.

After authorizing Makena, a hydroxyprogesterone caproate injection, under an accelerated approval pathway in 2011, the US Food and Drug Administration (FDA) has pulled approval for the drug. “[T]he touchstone of FDA drug approval is a favorable benefit-risk assessment,” FDA Commissioner Robert M. Califf, MD, said in a statement. “[W]ithout that favorable assessment, the drug should not have the status of being FDA-approved.”

Ricerca del team del National Cancer Centre di Singapore

Comunicato del 26/04/2023 n°19

Narcan, a 4-mg naloxone hydrochloride nasal spray that reverses the effects of opioid overdose, will soon be available for purchase without a prescription, the US Food and Drug Administration (FDA) announced in a statement.

New England Journal of Medicine, Ahead of Print.