Both Cologuard Plus and Shield were approved in 2024.
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FDA Greenlights First At-Home Syphilis Test to Help Speed Up Diagnoses
The US Food and Drug Administration (FDA) approved the first at-home test for syphilis for sale without a prescription. The test, manufactured by NOWDiagnostic and called First To Know Syphilis Test, arrives amid an 80% increase in cases in the US between 2018 and 2022, from 115 000 to 207 000 cases.
Studio con IA per predire fibrillazioni nelle donne e ictus
Cardiologia, al via ad Ancona guidato da professor Dello Russo
FDA Fast-Tracks First Nasal Spray for Allergic Reactions, Anaphylaxis
The US Food and Drug Administration (FDA) recently approved neffy, an epinephrine nasal spray, to treat emergency allergic reactions, including anaphylaxis. The spray is the first alternative treatment to epinephrine injections for adults and children who weigh at least 30 kg, or about 66 lb.
Psychedelic Therapy Scrutinized by FDA Advisory Committee
This Viewpoint analyzes the Psychopharmacologic Drugs Advisory Committee’s decisions regarding 3,4-methylenedioxymethamphetamine–assisted therapy and what they mean for psychedelic research.
Con 3 caffè al dì cala rischio diabete, ictus, malattia cardiaca
Minore multimorbidità cardiometabolica
Aifa approva 9 nuovi farmaci, fra questi 3 antitumorali
Il via libera dopo l’esame di 38 dossier
Ingesting Risk — The FDA and New Food Ingredients
New England Journal of Medicine, Ahead of Print.
Checks and Balances on FDA’s Authority
In this Viewpoint, the authors refute recent suggestions that the US Food and Drug Administration (FDA) is not accountable for its decisions, pointing out the legal, legislative, and executive checks and balances on the agency.
Controversial FDA Decision Authorizes Menthol-Flavored E-Cigarettes
This Medical News story examines the controversy surrounding the FDA’s first authorization of flavored e-cigarettes, in this case menthol.
Covid, Fda approva i vaccini aggiornati di Pfizer e Moderna
Saranno disponibili in Usa nei prossimi giorni
'Fda a giorni potrebbe approvare nuovi vaccini anti-Covid'
Cnn, l’ok a quelli aggiornati mRNA forse già questa settimana
FDA Green-Lights Second Alzheimer Drug, Donanemab
The US Food and Drug Administration (FDA) recently approved donanemab, a monoclonal antibody to treat Alzheimer disease in its early stages. Marketed by Eli Lilly as Kisunla, the drug is the second to receive the FDA’s go-ahead for slowing Alzheimer disease, after lecanemab. Like lecanemab, donanemab is designed to clear amyloid plaque in people with mild cognitive impairment or mild dementia.
FDA Proposes Guidance for Increasing Diversity in Clinical Trials
The US Food and Drug Administration (FDA) recently announced new draft guidance that aims to increase the number of participants from underrepresented populations in clinical trials in the US and globally by requiring medical product sponsors to submit strategies, known as diversity action plans. Age, ethnicity, sex, and race are all factors that can contribute to clinical trial diversity, but sponsors should also consider types of diversity beyond those, such as geographic location, sexual orientation, or socioeconomic status, the FDA wrote.
Origins of “Confidential Commercial Information” at the FDA
This Viewpoint reviews regulations regarding FDA’s handing of confidential commercial information, explains how these regulations serve as a barrier to disclosure of information in the interest of public health, and suggests how information could be carefully shared to improve health outcomes and advance research.
FDA Approval of Mifepristone
This Viewpoint discusses the recent US Supreme Court ruling allowing mifepristone—a drug used in medication abortion—to be widely available in the US, summarizes the history of challenges to the availability of mifepristone, and highlights reasons for concerns that remain after the Court’s current ruling.