Today's Healthcare Pulse
FDA greenlights durvalumab combo for high‑risk bladder cancer
The FDA approved durvalumab (Imfinzi) combined with Bacillus Calmette‑Guerin for BCG‑naïve, high‑risk non‑muscle invasive bladder cancer. The POTOMAC trial enrolled 1,018 patients and showed a 32% reduction in disease recurrence risk (hazard ratio 0.68, p=0.015). Durvalumab is given at 1,500 mg IV every four weeks for up to 13 cycles.
Also developing:
By the numbers: Apogee Therapeutics raises $1.3B royalty financing
Serious Liver Injury Being Observed in Patients without Cirrhosis Taking Ocaliva (Obeticholic Acid) to Treat Primary Biliary Cholangitis
The FDA’s latest safety communication reveals that Ocaliva (obeticholic acid) is causing serious liver injury in primary biliary cholangitis (PBC) patients without cirrhosis, including cases that required liver transplants or resulted in death. In a post‑market trial, 7 of 81 Ocaliva‑treated patients needed transplants versus 1 of 68 on placebo, yielding a hazard ratio of 4.77. The agency urges clinicians to monitor liver tests frequently and to discontinue the drug at any sign of worsening function. This follows a 2021 restriction that barred use in advanced‑cirrhosis patients, a rule still being ignored in some cases.
FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis with the Multiple Sclerosis Medicine Glatiramer Acetate...
The FDA issued a new boxed warning for glatiramer acetate (Copaxone, Glatopa), highlighting a rare but potentially fatal anaphylactic reaction. Data from 1996‑2024 show 82 reported cases worldwide, including six deaths, with most events occurring within an hour of injection...
FDA Requires Warning About Rare but Severe Itching After Stopping Long-Term Use of Oral Allergy Medicines Cetirizine or Levocetirizine (Zyrtec,...
The FDA issued a drug safety communication warning that stopping long‑term use of oral antihistamines cetirizine (Zyrtec) or levocetirine (Xyzal) can trigger rare but severe itching (pruritus). Between April 2017 and July 2023, 209 cases—including 197 in the United States—were...
FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch Transderm Scōp (Scopolamine Transdermal System)
The FDA has issued a Drug Safety Communication adding a new warning to the Transderm Scōp scopolamine patch about serious heat‑related complications, including hyper‑temperature, hospitalization and death. The warning follows 13 reported cases worldwide—seven in the U.S.—with four hospitalizations and two...
FDA Requires Expanded Labeling About Weight Loss Risk in Patients Younger than 6 Years Taking Extended-Release Stimulants for ADHD
The FDA is requiring a uniform "Limitation of Use" label for all extended‑release stimulants used in ADHD treatment, warning that children under six years face higher drug exposure and a significant risk of weight loss. The agency’s analysis of clinical...
CDC Warns of Medetomidine in Illicit Drugs
The CDC issued a health advisory warning that the veterinary sedative medetomidine is increasingly appearing in the U.S. illicit drug supply. Seizure reports jumped 950% in 2024 and another 215% in 2025, now spanning at least 18 states with the...
Finnish Study Finds Children of Immigrant Parents Face Major Gaps in Mental‑Health Care
Researchers at the University of Turku analyzed 172,000 Finnish children and found that those with two immigrant parents are 60% less likely to receive treatment for anxiety and depression, while children with an immigrant father and Finnish mother are up...
FDA Is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use
The FDA has mandated that manufacturers of extended‑release/long‑acting opioid analgesics update their prescribing information to reflect new post‑marketing study results. Two large PMR studies (3033‑1 prospective cohort and 3033‑2 retrospective cohort) found that roughly 22% of long‑term users develop opioid...
FDA Removes Risk Evaluation and Mitigation Strategy (REMS) Program for the Antipsychotic Drug Clozapine
The FDA announced that, effective June 13 2025, the risk evaluation and mitigation strategy (REMS) for clozapine is being eliminated. While the drug’s potential to cause severe neutropenia remains, the agency concluded that updated labeling and a new Medication Guide provide sufficient...
FDA to Recommend Additional, Earlier MRI Monitoring for Patients with Alzheimer’s Disease Taking Leqembi (Lecanemab)
On August 28, 2025 the FDA issued a drug‑safety communication recommending an additional magnetic resonance imaging (MRI) scan before the third infusion of Leqembi (lecanemab) for Alzheimer’s patients. The agency’s analysis identified 101 serious cases of amyloid‑related imaging abnormalities with...
RFK Jr. Appointed a Saboteur to Run the CDC’s Vaccine Panel — And Didn’t Know It
Dr. Robert Malone, a co‑inventor of mRNA vaccine technology, quit the CDC’s Advisory Committee on Immunization Practices (ACIP) alleging internal sabotage. He claims that a person personally appointed by RFK Jr. to oversee ACIP operations acted as a mole, undermining Secretary...
How Jefferson Became the First to Achieve URAC Community Health Worker Accreditation
Jefferson Health became the first organization to earn URAC’s Community Health Worker Program Accreditation, establishing a national benchmark for CHW recruitment, training, and integration. The program has expanded from fewer than a dozen CHWs in 2023 to nearly 40 staff,...
K.C. Pharmaceuticals Recalls 3.1 Million Eye‑Drop Bottles Over Sterility Concerns
K.C. Pharmaceuticals announced a voluntary recall of over 3.1 million bottles of over‑the‑counter eye drops sold across the United States. The FDA classified the action as a Class II recall on March 31, 2026, citing a lack of assurance of sterility. The recall...
K‑38 Consulting Generates $2.3 Million Turnaround for Premier Orthopedic Associates
K‑38 Consulting announced a $2.3 million financial improvement for Premier Orthopedic Associates after a 12‑month revenue‑cycle transformation. The boutique firm cut days in accounts receivable by 40%, slashed denial rates to under 5%, and boosted net collection to 96.2%, underscoring the...
Ottawa Takes Charge of Vaccine Injury Compensation Program
The Canadian government has assumed direct control of the Vaccine Impact Assistance Program, moving it from the private consultancy OXARO to the Public Health Agency of Canada. The program, a no‑fault scheme, compensates individuals with serious, permanent injuries linked to...
WELL Health and AliveCor Team Up to Cut Cardiology Wait Times with AI‑Powered ECG Review
WELL Health Technologies has struck a strategic partnership with AI‑leader AliveCor to embed Canadian‑licensed cardiologists into the Kardia platform. The service promises clinician‑reviewed ECG results within 24 hours, targeting a 53% rise in elective cardiology wait times and an average...
Nanotech Study Shows Targeted Reprogramming of Scar and Dermatitis Skin Microenvironments
Researchers published in the Journal of Pharmaceutical Investigation that multifunctional nanoparticles can reprogram pathological skin microenvironments, delivering anti‑inflammatory and antifibrotic agents directly to scar tissue and atopic dermatitis lesions. The approach modulates immune cells and fibroblast activity, promising more effective,...
Trump Targets NIH Funding Amid $1.5T War Spend
Trump once again going for draconian cuts to NIH, though not as catastrophic as he sought for the last round (and didn't get). Meanwhile, he wants $1.5T for war. I doubt he'll be any more successful with NIH cuts than...
Data Breaches Hit Hims & Hers and TriZetto, Exposing Millions of Patient Records
Telehealth giant Hims & Hers confirmed a hack of its customer‑service ticketing system, while Cognizant‑owned health‑tech insurer verification platform TriZetto disclosed a breach that exposed over 3.4 million patient records. Both incidents underscore growing cyber risks in digital health infrastructure.
A Personality Change Like This May Signal Dementia
A seven‑year longitudinal study published in the Journal of the American Geriatrics Society found that increases in neuroticism and decreases in openness often precede the clinical onset of Alzheimer’s disease. Researchers observed that personality shifts, especially heightened anxiety, depression, and...
Prilenia and Ferrer Launch $500‑Patient Phase‑3 ALS Trial of Pridopidine
Prilenia Therapeutics and Ferrer have opened enrollment for the PREVAiLS phase‑3 trial of pridopidine, a sigma‑1 receptor agonist, in 500 early‑stage ALS patients. The study spans up to 60 sites in 13 countries and builds on mixed results from a...
MUSC Health Uses AI Analytics to Gain OR Scheduling Efficiencies
MUSC Health adopted Apella's ambient AI platform to replace manual EHR timestamps with automated, real‑time operating‑room event tracking. The technology delivered six‑fold more accurate timestamps and updates within a minute, instantly visible to charge nurses and coordinators. Within weeks, 100%...
Scientists Urge EPA Not to Weaken Ethylene Oxide Emissions Standards
Scientists, clinicians, and community groups urged the EPA to keep its 2024 ethylene oxide (EtO) emissions standards for medical device sterilizers. The agency’s March proposal would lift restrictions, allowing an additional 7.8 tons of EtO per year and eliminating permanent enclosures...
Restore Robotics Cleared to Remanufacture 2 More Da Vinci Xi Instruments
Restore Robotics received FDA 510(k) clearance for two additional da Vinci Xi instruments—a permanent cautery hook and a permanent cautery spatula—bringing its total FDA‑cleared remanufactured instruments to four. The clearances follow earlier approvals for da Vinci scissors and expand the company’s portfolio of...
Health Insurance Waiting Periods: An Unjust, Normalized Scam
Waiting periods for health insurance is such a scam. Where else is it normalized for you to pay for something you can’t actually use for months?
EPA’s Draft CCL6 Adds Microplastics, Drugs In MAHA Alignment
The Environmental Protection Agency released a draft of its sixth Contaminant Candidate List (CCL6) that formally includes microplastics and pharmaceutical residues as chemical groups for possible future drinking‑water regulation. The move mirrors demands from the Make America Healthy Again (MAHA)...
The Riskiest Way to Prove You’re Right
For decades the medical establishment blamed stress for stomach ulcers, dismissing any bacterial cause. Dr. Barry Marshall, alongside pathologist Robin Warren, identified Helicobacter pylori as the culprit but faced widespread skepticism. To force acceptance, Marshall deliberately ingested a culture of...
Molecular End Points Poised to Transform Myeloma Drug Approval: Nicholas Richardson, DO, MPH
The FDA released draft guidance proposing minimal residual disease (MRD) negativity and complete response as primary endpoints for accelerated approval of multiple myeloma therapies. MRD is defined as fewer than one myeloma cell per million bone‑marrow cells, measured by flow...
Creating a Roadmap to Scale up Prenatal Supplementation Across Africa
Policymakers at the 2024 Africa Maternal Nutrition and MMS Technical Meeting outlined a unified framework to scale multiple micronutrient supplementation (MMS) for pregnant women across the continent. Evidence shows MMS reduces anemia‑related infant mortality by 29% and improves growth outcomes,...
Height or Weight, Which Is a Bigger PJK Risk Factor? (Not a Trick Question)
A multicenter retrospective review of 904 adult spinal deformity patients found that height, not weight, independently predicts proximal junctional kyphosis (PJK) after surgery. The risk rises with stature, peaking near 179 cm, and then plateaus. Weight and the height‑weight interaction showed...
Evidence‑Heavy Statins Still Outpace Unproven Peptides
There is a fascinating op-ed piece in STAT from a doctor whose patient rejected a statin -- one of the most tested drug classes in existence -- but chose to take an untested peptide for cardiovascular risk. "My patient is intelligent,...
Leucovorin for Autism: Why Physicians Must Protect Hope From Hype
Physicians warn that leucovorin, a folate derivative, is being hyped as an autism cure after political endorsements, despite lacking robust clinical evidence. Small studies suggest modest language gains, but no large randomized trials have confirmed efficacy and reported side effects...
Soquelitinib
Corvus Pharmaceuticals announced soquelitinib (CPI‑818), an oral covalent inhibitor that irreversibly engages ITK at Cys442 while sparing the related kinase RLK. The selectivity addresses the broader off‑target activity seen with earlier covalent ITK agents such as ibrutinib. Soquelitinib is currently...
‘Medicare By Choice’ Plans Could Work, But More Details Needed
Medicare by Choice is an aspirational Democratic proposal that would expand eligibility for Medicare‑like plans, add income‑based subsidies, and allow employers to offer the option to workers. The plan includes a public‑option competing with private insurers, caps on out‑of‑pocket costs,...
FTC Urges Tennessee to Preserve Ballad Health’s COPA
The Federal Trade Commission has written to Tennessee lawmakers urging them to keep Ballad Health’s Certificate of Public Advantage (COPA) in place, warning that its expiration would leave the state’s dominant hospital system without oversight. The Tennessee legislature is debating...
This Is Ascent Health Services – the Secretive Swiss Company at the Heart of the Express Scripts Scandal
Ascent Health Services, a Swiss‑registered group purchasing organization created by Cigna’s Express Scripts in 2019, channels billions of dollars in manufacturer‑paid fees that should be passed through as rebates. The GPO’s offshore structure lets Cigna and its partners keep these...
Unstable Jobs and Bureaucracy Push Families Into Health Crises
The latest episode of The Pitt shows how people fall through the cracks. A mom works as a hair stylist with unpredictable income and misses the Medicaid renewal notice when they changed apartments. Her teenaged son ends up in the...
Zenkuda Superior to Sham in Phase 3 Diabetic Retinopathy Study
Kodiak Sciences reported that its intravitreal biologic Zenkuda (tarocimab tedromer) outperformed sham in the phase 3 GLOW2 trial for diabetic retinopathy. At week 48, 62.5% of patients receiving Zenkuda achieved a two‑step or greater improvement on the Diabetic Retinopathy Severity Scale versus...
Despite Guidelines, Aspirin Is Used in Fewer Than One in Four High-Risk Pregnancies
Researchers at Mass General Brigham analyzed 21,326 women (30,767 pregnancies) and found that only 24% of high‑risk pregnancies received low‑dose aspirin by 2023, despite USPSTF recommending it since 2014. Preeclampsia affects up to 7% of pregnancies and raises both short‑term...
Smarter Documentation Is Changing EMS Operations
Emergency medical services (EMS) agencies are adopting AI tools to streamline documentation, a long‑standing bottleneck. Voice‑to‑text and optical character recognition (OCR) now capture patient data in real time, reducing manual entry and errors. Administrators benefit from AI‑driven search, quickly surfacing...
8‑9½ Hrs Sleep, 40‑105 Min Exercise Cuts MACE 57%
https://t.co/IOM6UP2RJ0 "The best combination included sleeping for about 8 to 9.5 hours per night, getting in roughly 40 to 105 minutes of moderate-to-vigorous activity daily, and maintaining a higher-quality diet. This combination had a 57% lower MACE risk." #lifestylemedicine #pavingwellness #health...
AI Drives Value‑Based Care Revolution in Hospitals
Healthcare must be redesigned around early intervention, accountability, and outcomes, and artificial intelligence can help make this a reality. A decisive transition to value-based care, powered by AI, can fundamentally change how hospitals operate and help us reimagine how physicians...
Maternal COVID-19 Vaccination Protects Infants for up to 6 Months
A Norwegian cohort study of 146,031 infants found that mothers who received mRNA COVID‑19 vaccines during pregnancy reduced their babies' risk of COVID‑19 hospitalization by 36%. The protective effect was strongest in the first five months of life and faded...
Geography Determines Newborn Screening Access, Not Health
‘Death by ZIP Code’: Newborn Screening and the Geographic Screening Lottery -- Excellent piece by my colleague @GrinsteinJ https://t.co/K0mVN4Ydbk via @Inside_PM
Med Student Ursula Gately Connects the Climate to the Clinic
Second‑year Johns Hopkins medical student Ursula Gately will speak at the Hop Talks event on April 7, highlighting how planetary health can be turned into concrete community‑health actions. Gately draws on her personal experience with valley‑fever and her work with the...
It’s Not Just Patients Who Are Sick of Fighting Health Insurers. Doctors Are Frustrated, Too.
Health insurers are leveraging administrative tactics like extensive prior authorizations and prolonged accounts‑receivable cycles to boost profits, resulting in record‑breaking payer margins. Physicians, especially independent surgeons, are confronting millions of dollars in unpaid claims and cash‑flow strain, forcing staff cuts...
Calcium Score Predictive of ASCVD Risk From Elevated Lp(a)
Researchers analyzing data from 11,319 participants across four major cohorts found that elevated lipoprotein(a) levels (>50 mg/dL) and a coronary artery calcium (CAC) score above zero each independently increase the risk of atherosclerotic cardiovascular disease (ASCVD). The combination of high Lp(a)...
Patients Want High-Quality Care, Provider Choice, Affordability
Dr. Richard L. Lindstrom argues that patient satisfaction in eye‑care hinges on three core desires: convenient high‑quality access, the ability to choose a provider, and perceived value or affordability. He cites that roughly 20% of U.S. health‑care encounters leave patients...
HIMSS26 Changemaker Reframes Healthcare IT Work as Public Service
At HIMSS26 Changemaker, Colorado Lt. Governor Dianne Primavera urged aspiring healthcare IT professionals to view their work as a public service. She emphasized building technology that is intuitive and directly improves patient experiences. Primavera highlighted the moral responsibility of developers...
Brain‑Network Signal Predicts Depression Therapy Success in New Study
Scientists led by Kaizhong Zheng and Liangjun Chen discovered a brain‑network connectivity pattern that predicts whether patients with major depressive disorder will respond to antidepressants. Analyzing scans from 4,271 participants, their machine‑learning model distinguished future responders with high accuracy, opening...