FDA Updates Sotrovimab Emergency Use Authorization
The U.S. Food and Drug Administration revoked the Emergency Use Authorization for sotrovimab on April 5, 2022, after CDC data showed the Omicron BA.2 sub‑variant accounted for more than 50 % of cases in every HHS region. Earlier in the year the agency had incrementally limited the drug’s use as BA.2 spread, but the latest data indicated the authorized dose would not be effective against the variant. The FDA now advises clinicians to rely on other authorized treatments such as Paxlovid, Veklury, bebtelovimab, or molnupiravir. Ongoing surveillance will guide any future EUA adjustments.
Advancing Novel Surrogate Endpoints For Rare Disease Drug Development Workshop - 05/18/2026
The FDA is hosting a virtual workshop on May 18, 2026 to advance novel surrogate endpoints for rare disease drug development. The event is part of the Rare Disease Endpoint Advancement (RDEA) Pilot Program, mandated by PDUFA VII and FDORA, which requires up...
FDA Works to Protect Consumers From Potentially Harmful OTC Skin Lightening Products
The U.S. Food and Drug Administration issued warning letters to twelve companies for selling over‑the‑counter skin‑lightening products that contain hydroquinone, an ingredient not approved for OTC use. The agency highlighted serious adverse events such as rashes, facial swelling, and permanent...
New Nasal Flu Vaccine Shows Promise in Mice
Researchers at Georgia State University have engineered an intranasal influenza vaccine that uses cell‑derived extracellular vesicles (EVs) to display inverted hemagglutinin (HA) proteins. The upside‑down HA exposes the conserved stalk region while masking the variable head, prompting cross‑protective immunity. In...
HeyDonto AI Technology Closes $20M Seed Round at $200M Valuation to Scale Conduit — The Dental Interoperability Exchange
HeyDonto AI Technology announced a $20 million seed round that values the company at $200 million. The capital will be used to scale Conduit, its AI‑powered dental interoperability platform that links dental practice systems with medical EHRs, payers and patient apps. Conduit...
Patients Are Using Chatbots to Fight Medical Bills, With Mixed Results
Patients are increasingly turning to free AI chatbots like Claude and ChatGPT to dispute medical bills, exemplified by a couple who used Claude to challenge a $22,604 emergency‑room charge. The American Hospital Association has flagged this growing DIY trend as...
Merck Adjusts Its Vaccine Supply Deal in China; Soleno Withdraws EU Application
Merck and its Chinese partner Zhifei have revised their COVID‑19 vaccine supply agreement, lowering the committed volume and adding a flexible delivery schedule to reflect waning demand. The updated contract preserves Zhifei’s exclusive distribution rights but shifts risk back to...
Jeito Capital, Prominent Biotech Investor, Raises $1.2B for Next Fund
Jeito Capital announced the close of its Jeito II fund, raising €1 billion (about $1.2 billion) – the largest capital raise ever for an independent European biopharma fund. The fund will back 15‑20 clinical‑stage drugmakers, allocating up to €150 million ($162 million) per company across...
Skilled Nursing Facilities Get a Proposed 2.4% Increase
The Centers for Medicare & Medicaid Services (CMS) has proposed a 2.4% increase to the Skilled Nursing Facility Prospective Payment System for fiscal year 2027, derived from a 3.2% market basket adjustment offset by a 0.8% productivity factor. Facilities that...
Rune Labs Launches StrivePD Guardian, an AI Companion for Parkinson’s Disease Powered by Claude
Rune Labs has introduced StrivePD Guardian, an AI‑powered companion for Parkinson’s disease that operates as an agentic system. The app, built on Anthropic’s Claude model, routes patient queries to specialized sub‑agents such as a Medication Assistant and PD Coach, while...
Gilead Takes Another Big Swing at Expanding Beyond HIV
Gilead Sciences has earmarked roughly $11 billion this year for three strategic acquisitions aimed at strengthening its cancer and immunology pipelines. The moves signal a decisive pivot away from its historic reliance on HIV therapeutics toward broader biotech markets. The targeted...
AI Uncovers Significant Misdiagnoses in Carcinoma Type, Study Shows
Caris Life Sciences published a JAMA Network Open study showing its GPSai algorithm identified misdiagnoses in lung squamous cell carcinoma (SCC). Among nearly 4,000 cases, 123 (3.1%) were re‑classified as metastases from other primary sites. The AI model combined molecular,...
New Light Shed on Who Benefits Most From Weight-Loss Jabs
A new study published in Nature examined 15,000 people who used GLP‑1 weight‑loss drugs such as Wegovy and Mounjaro and found that two genetic variants linked to appetite and digestion significantly boost weight loss and increase nausea risk. Carriers of...
Greenway Health Works With Customers to Implement Agentic AI Features
Greenway Health has launched Novare, an agentic‑AI‑powered EHR platform that rebuilds its clinical, revenue‑cycle and patient‑engagement services from the ground up. The system offers ambient note‑taking, voice‑activated chart search, intelligent coding, automated prior authorizations and real‑time benefit checks, aiming to...
Readers Write: Chatbots Are Repeating a Familiar Healthcare Mistake
Reader commentary highlights that AI‑driven chatbots are echoing long‑standing digital‑health missteps. Without clear federal or state mandates, health systems risk deploying fragmented tools that compromise patient safety and data security. The author urges providers to view chatbots as integral components...
New Gene Therapy May Help Protect the Hearts of Patients with Friedreich's Ataxia
Lexeo Therapeutics reported early-phase results for its investigational gene therapy AAVrh.10hFXN (LX2006) in Friedreich’s ataxia–associated cardiomyopathy. In a phase 1 trial of 17 adults, a single intravenous infusion was well tolerated and produced signals of cardiac improvement, while neurological scores remained...
ICHRAs, a Growth Opportunity for Insurers, Face Uphill Battle
Individual Coverage Health Reimbursement Arrangements (ICHRAs) are gaining traction as insurers search for growth amid stagnant commercial plan enrollment. Adoption jumped 19% from 2024 to 2025, with a 34% surge among large employers, prompting payers like Centene and Oscar to...
Wildflower Once Used to Treat Wounds and Sore Throats Shows Promise in Fighting Dangerous Superbugs
Researchers at Irish universities have demonstrated that extracts from the wildflower tormentil (Potentilla erecta) possess strong antimicrobial activity against multidrug‑resistant bacteria, including strains that cause pneumonia and urinary‑tract infections. The study identified ellagic acid and agrimoniin as the key compounds...
Brokers Poised to End the Healthcare Heist
Louis C. Bernardi argues that the U.S. health‑benefits system persists because it exploits human aversion to change, not because it is efficient. Brokers and consultants, conditioned by renewal cycles and carrier‑centric products, often reinforce this inertia, allowing employers to accept...
Frazier Healthcare Partners Taps Randy Hyun for Exec in Residence
Frazier Healthcare Partners has appointed Randy Hyun as an executive in residence, a role designed to scout and evaluate new investment opportunities. Hyun will concentrate specifically on the pharmacy services sector, leveraging his industry experience to identify high‑growth targets. The...
Payer Denials and Prior Authorization Delays Are Top RCM Concerns
A recent HFMA/Guidehouse survey finds payer denials and prior‑authorization delays are the top revenue‑cycle concerns for hospitals. While 78% of respondents already use AI automation for manual RCM tasks, 59% have not applied AI to the revenue cycle itself. Denials...
Closing Care Gaps with Wearables
American College of Cardiology (ACC) Chief Innovation Officer Dr. Ami Bhatt warned that wearable devices that flag disease risk must do more than alert users—they need to steer patients toward appropriate care pathways. As wearables become capable of detecting early...
Pemivibart Shows Safety, Prevents COVID-19 in CLL Subset in Phase 3 CANOPY Trial
A phase 3 CANOPY subset analysis evaluated pemivibart, a recombinant IgG1 monoclonal antibody, for pre‑exposure COVID‑19 prophylaxis in patients with chronic lymphocytic leukemia (CLL). Among 29 CLL participants, none developed symptomatic SARS‑CoV‑2 infection over a 180‑day follow‑up, and the safety profile...
Inside the Talkspace-Universal Health Services Deal
Talkspace, the pandemic‑era teletherapy platform, agreed to be acquired by Universal Health Services (UHS) in a deal valued at roughly $600 million in cash and stock. The transaction gives UHS a digital mental‑health capability across its 400‑plus hospitals and outpatient centers....
Childhood Dementia Explained by Synaptic Dysfunction, Opens New Therapies
Researchers at Flinders University used human iPSC-derived cortical neurons to model Sanfilippo syndrome, revealing that excitatory synapses become hyperactive early in development. This chronic overactivity mirrors the hyperactivity and sleep disturbances observed in affected children and appears to drive cognitive...
Beyond Consumer Use, Wearables May Be at a Clinical Turning Point
Wearable devices are moving from fitness accessories to clinical tools, as highlighted by Dr. Ami Bhatt, chief innovation officer of the American College of Cardiology, at HIMSS26. Sensors embedded in smart watches and patches can detect subtle physiological shifts that...
Unions Play Key Role in Keeping Direct Care Workers in the Workforce, Suggests Study
A UCLA-led study published in JAMA Network Open finds that unionized direct care workers (DCWs) experience significantly lower turnover than their non‑unionized peers, cutting overall attrition from 45% to 37%. The reduction spans nonprofit, for‑profit, and public sectors, translating into...
Post-HSCT Gilteritinib May Improve Outcomes in R/R FLT3-Mutated AML
A systematic review of eight studies suggests that post‑transplant gilteritinib maintenance may markedly improve survival for patients with relapsed or refractory FLT3‑mutated acute myeloid leukemia. One‑year overall survival rates ranged from 72.3% to 100%, while two‑year overall survival hovered around...
Scientists Develop AI Tool to Spot Heart Failure Risk Five Years Before It Strikes
Oxford researchers have created an AI algorithm that reads routine cardiac CT scans to flag patients at risk of heart failure up to five years before symptoms appear. In a study of 72,000 NHS patients followed for a decade, the...
Cancer Risk Is Significantly Higher for Adults Who Have Never Married, Finds Large Study
A new U.S. study of over four million cancer cases finds adults who have never married face a markedly higher risk of developing cancer than those who are or have been married. The elevated risk spans most major cancer types,...
Rural Healthcare Transformation Has to Focus on the Real World, Not Techno-Fantasies
The CMS is rolling out $50 billion in Rural Health Transformation (RHT) grants to help under‑funded clinics streamline operations and improve care. Rural hospitals face chronic staffing shortages, shrinking patient volumes and thin margins, with more than 40% operating at a...
Sidewinder Therapeutics Raises $137 Million to Advance Bispecific ADCs
Sidewinder Therapeutics announced a $137 million Series B round, surpassing expectations and bringing its total capital to $162 million. The round was led by Frazier Life Sciences and Novartis Venture Fund, with participation from OrbiMed, DCVC Bio, Goldman Sachs, and others. The funding...
A New Way To Target Metastatic Cancer
Researchers have unveiled a protein‑based delivery platform that homes to lymph nodes and releases an immune‑activating antibody only in the presence of metastatic cancer. The two‑step system first accumulates in nodes after bloodstream injection, then opens in the tumor’s chemical...
Noninvasive Stool DNA Testing May Outperform Colonoscopy Long-Term in Real-World CRC Screening
A new microsimulation study published in the Journal of Medical Economics finds that three rounds of next‑generation multitarget stool DNA (mt‑sDNA) testing over ten years outperform a single colonoscopy in real‑world colorectal cancer (CRC) screening. Higher patient adherence—72% versus 38%...
Care Sector Recruitment Crisis Deepens as Fewer Workers Enter the Industry
A new analysis by Indeed’s Hiring Lab, reviewed by Caredemy, shows UK care homes facing a deepening recruitment crisis, with job‑seeker interest falling 15.9% since January 2025 and applicants per vacancy down 10.9%. The shortage is compounded by rising operating costs,...
Iowa AG Files Lawsuit Against Change Healthcare over 2024 Data Breach
Change Healthcare, a UnitedHealth Group subsidiary, faces a lawsuit filed by Iowa Attorney General Brenna Bird alleging violations of state consumer‑protection and data‑security laws. The suit stems from a February 2024 breach that went undetected for ten days, exposing Social...
Digital Health Funding Concentrates in Fewer Startups: Report
Digital health startups secured $4 billion in the first quarter of 2026, up $1 billion from a year earlier, but the capital was funneled into fewer deals. Only 110 transactions occurred, down from 122, while a dozen mega‑deals of $100 million or more...
Addressing the Crisis of Black Maternal Health: A Critical Role for Black Fathers
The United States faces a stark Black maternal health crisis, with mortality rates over 55 per 100,000 live births—more than triple the rate for white women. Over 80% of these deaths are deemed preventable through early intervention, yet systemic racism...
It’s Time to Put Guardrails on GLP-1 Compounding
The article warns that the rapid rise of compounded GLP‑1 drugs—spurred by a shortage of FDA‑approved semaglutide and tirzepatide—has created a largely unregulated market fraught with safety risks. The FDA recorded 1,150 adverse‑event reports, including hospitalizations and deaths, linked to...
Skipping the Line: The Rise of Personal Healthcare Agents and On-Demand Care
Personal health agents such as ChatGPT Health, Claude for Healthcare, Copilot Health and Doctronic are moving from pilot projects to mainstream consumer tools, promising instant, AI‑driven medical advice. Doctronic alone has logged over 15 million AI‑mediated conversations, achieving 99.2 % treatment‑plan alignment...
Jefferson Health Sues Aetna over Medicare Advantage ‘Downcoding’ Policy
Jefferson Health and Lehigh Valley Physician Hospital Organization have filed a federal lawsuit against Aetna, alleging that the insurer’s new “downcoding” policy unlawfully reduces Medicare Advantage inpatient payments. The policy classifies 1‑4 night admissions as low‑severity and reimburses them at...
Researchers Develop Graphene Nanodrum and AI Platform for Rapid Single-Cell Bacterial ID and Antibiotic Testing
Researchers at TU Delft, its spin‑off SoundCell, and Reinier Haga MDC have created a graphene‑based nanodrum platform that reads the nanomotion of individual bacteria and feeds the data to AI models for rapid identification and antibiotic susceptibility testing. The label‑free...
Hospital Expansion Reimagines Healthcare Settings with Spatial Layout
Fleurimont Hospital in Sherbrooke, Quebec, has completed a 34,500 m² (371,355 sf) expansion that adds the Enfant Soleil Pavilion, consolidating emergency, maternity, neonatal, pediatric and child‑psychiatry services. The project used a collaborative design process involving clinicians, artists, managers and patient partners to...
Extracellular Vesicles: A Growing Pipeline Still Searching for Validation
Extracellular vesicles (EVs), once hailed as natural delivery vehicles, have generated a sizable pipeline but no approved therapeutics yet. More than 90 clinical studies are evaluating both native MSC‑derived vesicles and engineered platforms for regeneration, gene editing, and vaccines. Companies...
MRNA Pioneer Katalin Karikó to Give Johns Hopkins Commencement Address
Nobel laureate Katalin Karikó will deliver the commencement address at Johns Hopkins on May 21. Karikó, whose mRNA work underpins the Pfizer/BioNTech and Moderna COVID‑19 vaccines, will receive a Doctor of Humane Letters. Her career, marked by early setbacks and decades‑long...
The Power Behind Enterprise EHR Software for Large Healthcare Systems
Enterprise electronic health record (EHR) platforms are becoming the operational backbone for large healthcare systems, offering a unified, cloud‑based architecture that supports multiple facilities, specialties, and tax entities. Core capabilities include real‑time data synchronization, API‑first interoperability, built‑in HIPAA and ONC...
Hospitals Still Drive the Largest HSA Dollars
Lively’s 2026 HSA Spend Report shows hospitals still command the biggest dollar volume, but retail giants, e‑commerce sites and digital health providers are rapidly climbing the merchant rankings. Amazon, Lilly, Warby Parker, 1‑800 Contacts and mental‑health platforms like BetterHelp now...
Insmed Scraps Skin Plans for Lung Disease Drug as Competitors Make Headway
Insmed announced it will drop development of its lung‑disease drug Brinsupri for hidradenitis suppurativa after the Phase 2b CEDAR trial showed no efficacy, with placebo outperforming both tested doses. The study also missed secondary endpoints, prompting the company to cease the...
The Complex Link Between Poverty and Health
The relationship between poverty and health is bidirectional and varies by context, making policy solutions complex. Research shows a steep health gain as income rises from extreme poverty, but additional wealth yields diminishing returns. Cash‑transfer programs produce mixed health outcomes,...
Asthma Exacerbations Drop with Medium-Dose ICS to Biologic Switch
A recent analysis of 2016‑2023 Optum claims data shows that asthma patients who switched from a medium‑dose inhaled corticosteroid (ICS) directly to a biologic experienced markedly larger reductions in exacerbations and systemic corticosteroid fills than those who escalated to high‑dose ICS....