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What's New: Vaccines, Blood and Biologics
10th Dec, 2025
FDA
Center for Biologics Evaluation and Research
STN: 125743 Proper Name: immune globulin intravenous human-stwk Tradename: ALYGLO Manufacturer: GC Biopharma Corp. Indication: Indicated for the treatment of primary humoral immunodeficiency (PI) in adults. Production Information Package Insert - ALYGLO Demographic Subgroup Information- immune globulin intravenous, human-stwk, ALYGLO Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable. Supporting Documents December 15, 2023 Approval Letter - ALYGLO December 15, 2023 Summary Basis for Regulatory Action - ALYGLO Approval History, Letters, Reviews, and Related Documents - ALYGLO
What's New: Drugs
Center for Drug Evaluation and Research
The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3) Good Clinical Practice.” This revision incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology. This important milestone marks a significant evolution in the global clinical trial landscape, aiming to modernize GCP principles in alignment with current scientific and technological advances while maintaining a strong focus on quality by design, participant protection, and the reliability of trial results. Key updates in ICH E6 (R3) include: Increasing flexibility to support a broad range of modern trial designs, data sources, and technology. Advancing quality by design and risk-based quality management in trial conduct and oversight. Clarifying sponsor and investigator responsibilities. Promoting proportionality, relevance, and critical thinking throughout the clinical trial lifecycle. This guideline also incorporates the perspectives of academic clinical trial experts to ensure the practical relevance of its provisions. ICH E6 (R3) is intended to encourage the use of technology and innovations, and it is designed to remain relevant and consistent as technology and methods evolve. The finalized guideline is the result of extensive global stakeholder engagement and public consultation. It reflects a flexible, harmonized framework that will support efficient, high-quality clinical trials across regions.
Diabetes & Endocrinology
31st Dec, 2025
The Lancet
The ability to reduce the risk of developing diabetic ketoacidosis (DKA) remains a major care gap for people with diabetes, particularly those on intensive insulin therapy. The anticipated availability of continuous ketone monitoring (CKM) has the potential to reduce the risk of developing DKA, one of the most life-threatening acute complications of type 1 and type 2 diabetes. International clinical guidelines have established ketone thresholds for suspected and confirmed diagnoses of DKA, based on use of point-of-care testing, as part of a triad of markers with allied thresholds for hyperglycaemia and acidosis.
Adrenal tumours have become a common incidental finding in the radiological evaluation of patients. Estimates suggest that 1–10% of the general population currently harbours an adrenal tumour, peaking in prevalence in the seventh and eighth decades of life. Advances in CT and MR have contributed to improved characterisation of adrenal masses, and novel radiopharmaceuticals are being developed for molecular characterisation and disease subtyping. As a result, the imaging and management of adrenal tumours have been important subjects of many guidelines and consensus statements.
The trajectories of type 2 diabetes and cancer following a diagnosis of prediabetes varied substantially by age at prediabetes diagnosis and, to a lesser extent, other sociodemographic and lifestyle factors, with most younger individuals (aged <55 years) remaining in the prediabetes state. Strategies to improve the prevention and early identification of type 2 diabetes and cancer in individuals with prediabetes should be tailored to the age at which prediabetes is diagnosed.
Diabetes subgroups could inform on outcomes, as well as guide treatment and follow-up needed for newly diagnosed individuals with diabetes. SIRD stands out as a high-risk subgroup that is not identified by conventional glycaemia-based risk factors, but bears risk of early onset end-organ damage and would benefit from identification and treatment before the diagnosis of diabetes.
Declines in heart failure mortality in both people with and without diabetes were less marked than were declines in CHD and cerebrovascular disease mortality in most jurisdictions. Heart failure mortality rate ratios have not decreased. A greater focus on reducing heart failure mortality in people with and without diabetes might be required.
Li M, Dal Maso L, Pizzato M, Rumgay H, Vaccarella S. Thyroid cancer in adolescents and young adults: a population-based study in 185 countries worldwide. Lancet Diabetes Endocrinol 2025; published online Nov 19. https://doi.org/10.1016/S2213-8587(25)00289-X—In Figure 6, two erroneous data points have been deleted from the scatter plot (one in part A and one in part B). This correction has been made as of November 21, 2025, and will be made to the printed version.
In April 2025, Kevin Hall took early retirement from the US National Institutes of Health (NIH). “My life's work has been to scientifically study how our food environment affects what we eat, and how what we eat affects our physiology. Lately, I've focused on unravelling the reasons why diets high in ultra-processed food are linked to epidemic proportions of chronic diseases such as diabetes and obesity”, explained Hall, in a post to social media. “Recent events have made me question whether NIH continues to be a place where I can freely conduct unbiased science.
Multiple factors contribute to rising obesity rates. However, excess caloric intake remains the primary driver. This conclusion is supported by multiple lines of evidence, including observational studies, and is intuitively plausible: consuming several hundred calories can take mere minutes, whereas expending the same amount often requires hours of sustained physical activity.1 Obesogenic environments have exacerbated this imbalance.2
The presymptomatic progression of type 1 diabetes is well characterised in children but remains poorly understood in more than 50% of cases that develop in adulthood.1 This knowledge gap is particularly important following the approval in 2022 from the US Food and Drug Administration (FDA) of teplizumab to slow down early type 1 diabetes progression in children and adults, as well as its subsequent approval by the European Medicines Agency (EMA). Studying type 1 diabetes before symptom development is challenging because islet autoantibody screening is required to identify those at risk and type 1 diabetes is rare, occurring in approximately 1 in 200 people.
Impaired glucose tolerance and impaired fasting glucose have long been recognised as risk factors for type 2 diabetes development. The term prediabetes was introduced by the American Diabetes Association (ADA)1 in 2011, with the intention to recognise intermediate glucose values between normal and diabetes as a risk factor for development of type 2 diabetes and to encourage clinicians to recommend lifestyle modifications to delay progression to type 2 diabetes. Over the past decade, strong associations have been shown between prediabetes and risk for cardiovascular diseases, chronic kidney disease, early-onset dementia, and some cancers, such as colorectal, breast, and pancreatic cancer,2,3 suggesting that prediabetes is a disease with broader implications on health.
There is increasing interest in delineating the heterogeneity of diabetes to develop precision diabetology.1 In 2018, Ahlqvist and colleagues2 introduced unbiased phenotype-based clustering to subtype diabetes into five clusters using the Swedish All New Diabetics in Scania 1 (ANDIS1) cohort, which was validated in the German Diabetes Study3 and replicated in many cohorts worldwide. Now, in The Lancet Diabetes & Endocrinology, Olaf Asplund and colleagues4 report on the follow-up of ANDIS1 (median follow-up 9·63 years [IQR 4·05]) as well as on an additional 10 019 participants with newly diagnosed diabetes in ANDIS2 (median follow-up 2·83 years [2·76]).
Cardiovascular disease (CVD), a composite of coronary heart disease (CHD), cerebrovascular disease, and heart failure, remains the leading cause of morbidity and mortality worldwide. Although mortality due to CHD has shown major decreases in high-income regions,1 these declines have not been noted in the case of heart failure. Diabetes represents a major risk factor for the development of heart failure, and is also associated with increased risk of progression from asymptomatic to symptomatic heart failure.
Pulmonary Medicine
11th Mar, 2026
Journal of the American Medical Association
Invasive mechanical ventilation, one of the defining interventions in critical care medicine, is received by more than 20 million patients annually in intensive care units (ICUs) worldwide. In any given ICU, usually half or more of patients require invasive ventilatory support. Among those needing at least 2 days of mechanical ventilation, the ICU mortality rate is high (>30%), as is the proportion of patients with difficult or prolonged weaning (>35%). Invasive mechanical ventilation, one of the defining interventions in critical care medicine, is received by more than 20 million patients annually in intensive care units (ICUs) worldwide. In any given ICU, usually half or more of patients require invasive ventilatory support. Among those needing at least 2 days of mechanical ventilation, the ICU mortality rate is high (>30%), as is the proportion of patients with difficult or prolonged weaning (>35%).
9th Apr, 2026
Center,
Research
Office,
Investigations
8th Apr, 2026
11th Apr, 2026
