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Source: National Heart, Lung, and Blood Institute - Related MedlinePlus Pages: Healthy Sleep
The latest headlines across every section, pulled from official and open-access sources.
Source: National Heart, Lung, and Blood Institute - Related MedlinePlus Pages: Healthy Sleep
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
YARTEMLEA is a prescription drug that is a MASP-2 inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
Edwards Lifesciences is expected to introduce the new device to surgical heart valve customers this year in a “measured, targeted rollout,” one analyst said.
The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an ANDA referencing that NDA drug product.
CAR-T cell therapy has flourished since it was first used in 2010, leading to seven approved medicines for different blood cancers. But adapting the powerful technique, which involves engineering a patient’s own T cells to fight cancer, to solid tumors has proven a vexing challenge.
Provide innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.
The Innovation Accelerator provides innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.
To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities
The July 1 changes are being framed as student loan policy. But they raise a larger question about what kind of labor, and whose labor, America is willing to invest in. The post Federal Loan Policy Is Pricing Women Out of Healthcare’s Most Critical Roles appeared first on MedCity News .
FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area.
by Mulugeta Ayalew Yimer, Alemayehu Teklu Toni, Nahom Worku Teshager, Degalem Tilahun Worku, Mulat Asrade Alemayehu, Yalew Melkamu Molla, Zewudu Andualem, Asefa Adimasu Tadesse Background Childhood cancer survival in low-income countries remains below 20%, with late recognition and delayed referral commonly reported. In Northwest Ethiopia, care providers often lack the knowledge, skills, and support systems for recognizing early warning signs of pediatric malignancies. Community caregivers often present only after symptoms become advanced. The University of Gondar Comprehensive Specialized…
On July 23-24, 2026, the Committee will discuss bulk drug substances being considered for inclusion on the 503A Bulks List.
Centralized knowledge repository for clinical trial innovation
Current AI tools often increase the disruption that radiologists already experience from using non-integrated platforms. The post Radiologists Need AI That Works Where They Work, Not Standalone Software appeared first on MedCity News .
We aren’t killing the problem that fax created. We are migrating it into a format that carries a higher expectation of automated processing — without yet having solved the underlying challenge that made automation hard in the first place. The post Don’t Celebrate the Wrong Win: What CMS-0053-F Actually Changes appeared first on MedCity News .
Efficacy supplement (new or revised indication). cream, topical. Sponsor: Arcutis
Objectives To assess the outcomes of patients undergoing open abdominal surgery at a National Referral Hospital in Tanzania. Design A prospective, observational, single-arm cohort study. Setting Dar es Salaam, Tanzania. Participants Patients who underwent open abdominal surgery between August 2022 and July 2023 were included. Patients were enrolled if they provided informed consent to participate and were ≥18 years of age. Patients were excluded if they were lost to follow-up, were admitted outside the department of surgery or were still admitted since the index surgery at the end of the…
Objective To assess changes in lipid-lowering therapy (LLT) use and low-density lipoprotein cholesterol (LDL-C) goal attainment through 1-year follow-up in patients stratified by diabetes status in SANTORINI (Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events in Europe – a MultInatioNal ObservatIonal study). Design Prospective, observational study. Setting 623 primary (general practitioners, internal medicine specialists or internists) and secondary (cardiologists, diabetologists, lipidologists or neurologists) care sites in 14 European…
Background Problem gambling among sexual and gender diversity (SGD) populations has received increasing attention in research. While the literature shows that these populations are more likely than others to experience addiction and mental health issues, little is known about gambling among them. In our online survey (n=1519), a group of SGD participants reported problematic gambling practices. Objective The present study, conducted as part of a broader mixed-methods study on gambling among SGD populations, aimed to gather qualitative data to gain insight into why problem gambling seemed high…
Objective To investigate whether IgG to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigens could reveal undetected SARS-CoV-2 exposure in a cohort of Malawian pregnant women participating in the REVAMP clinical trial. Design A secondary analysis of serological samples from a randomised controlled trial of iron supplementation in pregnancy, which began recruiting women in November 2018 and had its last visit occurring in September 2021. Setting Resource-limited setting in Zomba and Blantyre, Southern Malawi. Participants Pregnant women with ultrasound-confirmed singleton…
Introduction Interest in cold-stored platelets (CSP) has seen a resurgence over the last 20 years, having not been clinically used since the 1980s. A multitude of in vitro studies have reported positive characteristics such as improved haemostatic function and longer storage duration in CSP compared with their room-temperature-stored counterparts. More recently, CSP have been investigated in clinical trials and used to improve supply chain resilience in some settings. This systematic review and meta-analysis will synthesise and describe the published evidence on the therapeutic use of CSP to…
Background In singleton pregnancies, gestational diabetes mellitus (GDM) causes maternal and neonatal complications. However, this association remains unclear in twin pregnancies. This study aimed to investigate the association between GDM and obstetric outcomes specifically in twin pregnancies. Methods A retrospective cohort study was conducted among women with twin pregnancies from January 2018 to July 2022. Maternal and neonatal outcomes were compared between women with and without GDM. Adjusted ORs, 95% CIs and SEs were estimated using logistic regression, adjusting for maternal age…
Objective To explore how physiotherapists and osteopaths who use manual therapy in New Zealand conceptualise, reason about and manage upper back pain (UBP), a clinically relevant but inconsistently defined musculoskeletal presentation. Design Qualitative study using semistructured interviews and reflexive thematic analysis. The study was conducted and reported in accordance with best-practice qualitative guidance, including Consolidated Criteria for Reporting Qualitative Studies. Setting Private and public musculoskeletal practice settings across New Zealand. Participants 17 physiotherapists…