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Medical News
9th Dec, 2025
phys.org
A profound unraveling is underway in the American Southwest, happening across a thousand-mile arc from Santa Fe, New Mexico, to the central Sierra. In an unprecedented calamity, the most widely distributed, most iconic tree of the region—the beautiful ponderosa pine—is disappearing. So significant is this loss, both visually and ecologically, that it's reasonably fair to say it may be triggering the first post-climate-change landscape in America.
What's New: Vaccines, Blood and Biologics
FDA
Center for Biologics Evaluation and Research
STN: 125738 Proper Name: omidubicel-onlv Tradename: OMISIRGE Manufacturer: Gamida Cell Ltd. Indication: For the treatment of: Adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning. Product Information Package Insert - OMISIRGE Demographic Subgroup Information – omidubicel-onlv [OMISIRGE] 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 5, 2025 Approval Letter - OMISIRGE April 17, 2023 Approval Letter - OMISIRGE April 17, 2023 Summary Basis for Regulatory Action - OMISIRGE Approval History, Letters, Reviews, and Related Documents - OMISIRGE
Medical Journal
Oxford University Press
AbstractCardiology remains one of the most competitive medical specialties in the UK. This article provides practical guidance for aspiring cardiologists preparing for Higher Specialty Training applications. It outlines strategies to maximize portfolio scores, prepare effectively for interviews and adapt to recent changes in the scoring framework. The guidance also simultaneously supports the development of core skills essential for a successful career in cardiology.
What's New: Drugs
Center for Drug Evaluation and Research
[12/8/2025] The U.S. Food and Drug Administration (FDA) has qualified the first AI drug development tool, the AI-Based Histologic Measurement of NASH (AIM-NASH), to help pathologists assess metabolic dysfunction-associated steatohepatitis (MASH) disease activity in clinical trials. This cloud-based tool helps pathologists score liver biopsy components, including fat infiltration (steatosis), inflammation (hepatocellular ballooning and lobular inflammation), and scarring (fibrosis) stage. MASH, a significant public health challenge affecting millions of Americans, is a severe form of metabolic-associated fatty liver disease that develops when fat buildup in the liver causes inflammation and scarring. MASH can lead to cirrhosis (severe liver scarring), hepatic decompensation (worsening of liver function), liver cancer, liver transplantation, or death. Currently in MASH clinical trials, multiple experts independently assess liver histology, a time-consuming process made complicated by variable scoring. AIM-NASH could help standardize histologic assessment and reduce the time and resources needed for MASH drug development. The AIM-NASH system uses AI algorithms to analyze images of liver biopsies and provides scores according to the NASH Clinical Research Network scoring system. The process keeps humans involved, as pathologists are fully responsible for final interpretation, reviewing the whole slide image and AIM-NASH outputs before accepting or rejecting the AI-generated scores. The qualification was based on comprehensive validation studies demonstrating that AIM-NASH-assisted comparisons to expert consensus were similar to individual pathologists’ comparisons to expert consensus.
[December 8, 2025] The U.S. Food and Drug Administration today approved the first generic version of Imvexxy® (estradiol vaginal inserts). This approval will provide women additional options for access to treatment of moderate to severe dyspareunia (painful sexual intercourse), a symptom of vulvar and vaginal atrophy, due to menopause by delivering a low dose of estradiol directly to vaginal tissue. The generic estradiol vaginal inserts are bioequivalent to the reference listed drug Imvexxy® and are available in the same 4 mcg and 10 mcg strengths. Generic drugs undergo rigorous FDA review to ensure they meet the same standards for quality, strength, purity, and stability as brand-name drugs. Generic drugs also have the same active ingredient, dosage form, strength, route of administration, and conditions of use as the brand-name drug. Generic drugs typically cost less than brand-name drugs, providing significant cost savings for patients and the healthcare system. Healthcare providers should review the full prescribing information for complete safety and dosing information.
Diabetes Journals
The American Diabetes Association (ADA) “Standards of Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee for Diabetes, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.
9th Apr, 2026
Center,
Research
8th Apr, 2026
11th Apr, 2026