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
Healthcare IT Is Not a Solo Act, Says HIMSS Changemaker
Julie Luengas, DNP, RN, the Chief Nursing Informatics Officer at Stony Brook Medicine, received the HIMSS Changemaker award and emphasized that no healthcare IT leader reaches the top alone. She highlighted collaboration, mentorship, and collective effort as essential drivers of career advancement in health technology. Luengas’ remarks reflect a broader industry push to nurture talent through shared learning and cross‑functional teamwork. The message underscores the evolving culture of healthcare IT leadership, where community support outweighs solitary achievement.
Year-Long Aerobic Exercise Preserves White Matter, Boosts Cognition
Effects of aerobic exercise and cardiorespiratory fitness on white matter free water fraction in older adults: a 1-year randomized controlled trial "These findings suggest that 1 year of aerobic training may reduce [Free Water Fraction] in the CC body and that higher...
North Carolina Foster Care Health Plan Blocks CAR T Therapy for 8‑Year‑Old Cancer Patient
Ollie Super, an 8‑year‑old foster‑care child with recurrent neuroblastoma, was denied enrollment in a CAR T‑cell clinical trial because North Carolina’s new specialized Medicaid plan for foster children will not cover the treatment. The decision highlights systemic gaps in the...
Patient Listening Session Summaries
The FDA Public Engagement Staff oversees a structured Patient Listening Session program, reviewing session requests on a quarterly basis. Sessions can be FDA‑requested or patient‑led, covering a wide range of conditions from rare diseases to common disorders. Summaries of each...
Olezarsen Doesn’t Lower Plaque Volume: Essence-TIMI 73b
Olezarsen, an antisense drug targeting APOC3, dramatically lowered triglycerides (‑64 %) and remnant cholesterol (‑72 %) in the Phase III Essence‑TIMI 73b trial, yet a 12‑month coronary CTA subanalysis showed no significant reduction in non‑calcified plaque volume versus placebo. The study involved 468 patients...
University of Michigan Shows Protein Nanoparticles Can Deliver Gene Therapy Without Viruses
Scientists at the University of Michigan engineered protein‑based nanoparticles that delivered DNA and mRNA into human liver, kidney and immune cells without using viral vectors. The proof‑of‑concept experiment showed successful gene activation and could lower the risk of immune reactions...
Novel Therapeutic and Trial Approaches for Lysosomal Storage Disorders with Polaryx’s Alex Yang — Episode 249
In episode 249 of the Xtalks Life Science Podcast, Alex Yang, JD, LLM, CEO of Polaryx, discusses the company’s mission to develop disease‑modifying small‑molecule therapies for rare pediatric lysosomal storage disorders. Yang leverages more than 25 years of experience across...
STAT+: Government Watchdog Urges FDA to Finalize Guidance for Advisory Committee Conflicts of Interest
The Government Accountability Office (GAO) reports that the FDA has still not finalized the financial conflicts‑of‑interest (COI) guidance for its advisory committees, despite a law mandating it 13 years ago. The agency also fails to publicly disclose how it evaluates...
FDA Warns Consumers Not to Purchase or Use Artri and Ortiga Products, Which May Contain Hidden Drug Ingredients
The FDA has issued a renewed public warning that over‑the‑counter products bearing the names “Artri” or “Ortiga” may contain undeclared prescription drugs such as dexamethasone, diclofenac sodium, and methocarbamol. Since April 2022, more than 30 consumers have reported severe health effects,...
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What Are Clove Cigarettes?
Clove cigarettes, known as kreteks, blend tobacco with ground clove buds and oil, delivering higher nicotine, tar and carbon monoxide than regular cigarettes. The eugenol in cloves numbs the throat, prompting deeper, longer inhalations and increasing exposure to carcinogens. The...
The Man Who Let Deadly Snakes Bite Him for 20 Years—And the Universal Antivenom Hiding in His Blood
A Wisconsin man, Tim Friede, let venomous snakes bite him for two decades, building a unique repertoire of antitoxin antibodies. Researchers at biotech firm Centivax isolated two of these antibodies and combined them with the toxin‑blocking drug varespladib, creating a...
To Counter China, FDA Chief Wants to Speed New Drug Trial Process
FDA Commissioner Marty Makary said the agency will slash the amount of non‑safety data required to launch new drug trials in the United States. The streamlined approach aims to eliminate redundant paperwork, focusing only on safety‑related information. Makary framed the...
The Connected Care Continuum: Enhancing Patient Care Across Settings
Healthcare providers are accelerating the shift toward a connected care continuum that spans hospitals, ambulatory clinics, post‑acute facilities and the home. Leaders at NewYork‑Presbyterian and PointClickCare stress that seamless, standardized data—delivered through integrated EHRs and modern APIs—must be actionable across...
IBS Awareness Month 2026: The Hidden Realities of IBS and the IBS Treatment Market
April 2026 marks IBS Awareness Month, spotlighting a condition that affects roughly 10‑15% of the global population and often goes undiagnosed. The campaign emphasizes education, stigma reduction, and earlier detection to improve quality of life. Meanwhile, the global IBS treatment...
How Your Clinical Notes Impact Military Veterans’ Disability Benefits
Clinicians’ progress notes are now the primary medical evidence for Veterans Affairs (VA) disability claims, and incomplete documentation is causing a surge in delayed or denied benefits. Last year veterans filed a record number of claims, with roughly one‑third rejected...
Sub-Q Bionics Closes $1.5M Pre-Seed
Sub‑Q Bionics announced the close of a $1.5 million pre‑seed round to fund its next‑generation lymphedema medical devices. The financing includes capital from the Mayo Clinic, Yeda – the Weizmann Institute’s tech transfer arm – and several private investors, with the...
Evolution of Pharmacotherapy in STEMI
The podcast examines how STEMI pharmacotherapy has transformed over the past 46 years, moving from routine fibrinolysis to routine primary PCI with potent antiplatelet regimens. It highlights the recent approval of zalunfiban, a fast‑acting glycoprotein IIb/IIIa inhibitor, for administration at first medical...
Pfizer, BioNTech to Pause COVID Vaccine Study Due to Low Enrollment
Pfizer and BioNTech announced the suspension of a FDA‑mandated post‑marketing study of their COVID‑19 vaccine due to insufficient participant enrollment. The trial, aimed at 25,500 adults aged 50‑64, was designed to assess safety, immune response, and efficacy against infection. Companies...
They Thought Their Hearing Was Gone Forever—Until Doctors Tried Something Radical
A 2025 Nature Medicine study showed that delivering a functional OTOF gene via an adeno‑associated virus dramatically improves hearing in patients with genetic deafness. Ten participants aged 1 to 24 across five Chinese hospitals experienced a reduction in hearing threshold...
Graphene 'Scaffold' Recruits Bone Cells and Helps the Body Regenerate Fractures
Researchers in Brazil have created a graphene‑based scaffold that repaired nearly 90% of bone fractures in rats within a month, outperforming existing biomaterials. The scaffold combines graphene with chitosan‑xanthan polymers derived from waste black liquor, a pulp‑and‑paper by‑product. Acting as...
Kailera Plots IPO to Fuel Obesity Pipeline
Kailera Therapeutics, after raising $1 billion across a $400 million Series A and $600 million Series B, is preparing an IPO to fund its obesity drug pipeline. Its lead candidate, ribupatide, has delivered up to 23.6% weight loss in Phase 3 injectable trials and 12.1% loss...
20/20 BioLabs Expands Longevity Test with Kidney Risk Tech
20/20 BioLabs announced an exclusive U.S. license with South Korea’s ROKIT Healthcare to embed its chronic kidney disease (CKD) prediction algorithm into the company’s OneTest for Longevity platform. The addition expands the test beyond inflammation biomarkers to provide early kidney...
Dispatch From Iran: 'How Will We Rebuild What We Have Lost?'
US and Israeli airstrikes have demolished more than 115,000 civilian structures across Iran, including over 750 schools, 300 healthcare centers, and 90,000 homes. The attacks have killed over 3,400 people, with at least 1,500 civilians among the dead, and injured...
Eli Lilly Opposes Push to Pass Trump's Drug Pricing Deals Into Law, CEO Says
Eli Lilly is publicly opposing the White House’s effort to turn its voluntary “most‑favored‑nation” (MFN) drug‑pricing agreements into law. The company, along with more than a dozen peers, signed MFN deals in 2025 to align U.S. prices with those in other...
Enlivex Clears Pivotal FDA Hurdle in Knee Osteoarthritis
Enlivex has secured FDA Investigational New Drug (IND) clearance to launch a global Phase 2b trial of its immunotherapy Allocetra for moderate‑to‑severe age‑related knee osteoarthritis. The study will be randomized, double‑blind, and placebo‑controlled, building on promising Phase 1/2a data from 134 patients....
Loargys (Pegzilarginase) Wins FDA Nod for Ultrarare Metabolic Disorder After Earlier Setbacks
The U.S. FDA granted accelerated approval to Loargys (pegzilarginase‑nbln) for treating arginase‑1 deficiency (ARG1‑D), an ultrarare metabolic disorder affecting roughly 250 Americans. Loargys, a recombinant human arginase‑1 enzyme, is the first therapy shown to lower plasma arginine levels, achieving about...
CDC Tweaks Recommendations for ‘Rabbit Fever’
The U.S. Centers for Disease Control and Prevention has issued its first revision in nearly 25 years to the prevention and treatment guidelines for tularemia, a zoonotic disease also known as rabbit fever. The new recommendations reorganize guidance into distinct...
Study: Eye Microbiome Unchanged by Contact Lens Wear
A new study published in Microbiology Spectrum examined the ocular surface microbiome and tear proteome of 25 contact‑lens wearers and 23 non‑wearers. The researchers found no significant differences in bacterial composition or tear protein expression between the two groups. While...
FDA Open To More Data On Rare Disease Drug Ersodetug Despite Missed Phase 3 Endpoint
Rezolute announced that the FDA remains open to reviewing additional data from its Phase 3 trial of the rare‑disease hypoglycemia drug ersodetug, despite the study missing its primary efficacy endpoint. The agency’s willingness suggests the experimental therapy could still move toward...
Single Payer Isn’t The Only Alternative Healthcare System For The U.S.
After the Affordable Care Act subsidies expired, millions of Americans saw premiums surge, reviving concerns about the uninsured. Lawmakers are pushing single‑payer proposals such as Medicare for All, but a Pew 2025 survey shows only 35% of adults support a...
Newly Qualified Paramedics Told to Apply for Jobs Abroad Due to Hire Freeze
The Welsh Ambulance Service has imposed a hiring freeze on newly qualified paramedics, leaving around 70 graduates without NHS band‑5 positions. Despite receiving millions of pounds in bursary funding (≈$1.3 million USD), students are being advised to look for work in...
Menopause Is a Heart Health Crisis for Women
Women’s hearts have been studied last, treated later, and too often… ignored. And it’s costing lives. We spend a third of our lives in menopause—a cardiovascular turning point—and yet the system still isn’t built for us. It’s time to change the conversation. It’s time...
Test Maps Circadian Rhythm Via Hair Sample
Researchers at Charité have created a hair‑based diagnostic that reads the activity of 17 clock‑related genes to pinpoint an individual’s chronotype. In a study of over 4,000 volunteers, the test showed that lifestyle factors—especially employment—shift internal clocks more than genetics...
TCTMD’s Top 10 Most Popular Stories for March 2026
March 2026’s most‑read TCTMD stories were dominated by ACC conference data and new dyslipidemia guidelines emphasizing earlier, intensive LDL lowering and routine CAC and Lp(a) screening. Large trials showed that Impella mechanical circulatory support did not improve outcomes in anterior...
Vaccinate Babies: Protect Lives and Futures
I’m not going to stop saying it. Vaccinate your babies. Vaccines save lives and futures 🤍pediatrician #parenting #vaccinessavelives
Researchers Unlock the Key to Axon Regeneration
Researchers at Icahn School of Medicine discovered that the aryl hydrocarbon receptor (AHR) acts as a molecular brake preventing axon regeneration after nerve injury. Genetic deletion or pharmacological inhibition of AHR in mouse models redirected neurons from a stress‑survival mode...
Report Shows How NIH Funding Ripples Through State, Local Economies Nationwide
United for Medical Research’s 2026 report finds NIH’s $36.5 billion FY ’25 budget produced a 250 % return, generating roughly $94 billion in economic activity and supporting over 390,000 jobs. The analysis maps the ripple effect of research dollars through equipment manufacturers, service...
Health Systems Split: Epic AI vs Third‑Party Solutions
Every health system on Epic is facing the same question: trust Epic’s Patient AI or go 3rd Party? Sutter and Hartford just chose opposite answers. My 4 thoughts: The news this week: → Sutter Health was the 1st health system to go-live...
CDC Halts Rabies, Mpox Testing Support over Staff Shortage
What could possibly go wrong? #CDC pauses support for states on testing for #rabies & #mpox because it doesn't have the personnel to do the work. 2 pathogens you really don't want to mess with, rabies & mpox. https://t.co/Vr80XIP1J4
Novo Cuts 400 Jobs in Indiana as Scholar Rock Refiles Drug Linked to the Factory
Novo Nordisk announced it will cut approximately 400 positions at its recently acquired Bloomington, Indiana manufacturing plant. The cuts follow FDA rejections of drug products from three contract companies that used the facility, citing manufacturing deficiencies. The issues stem from...
Light Therapy Eases Fatigue in Hashimoto’s Patients
The effect of photobiomodulation therapy on fatigue and behavioural status in patients with Hashimoto’s thyroiditis https://t.co/AJx5dvqHyw
Doctors Will Swap Pills for Gene Therapies and Epigenetics
Longevity 2.0: Your next doctor won't prescribe pills—they'll prescribe gene therapies, epigenetic reprogramming, and personalized longevity protocols. Medicine is shifting from "treat symptoms" to "reverse aging at the cellular level."
India and WHO Launch Yoga Modules to Tackle Lifestyle Diseases
India's Ministry of AYUSH and the World Health Organization rolled out a suite of standardized yoga modules designed to prevent and manage lifestyle diseases such as diabetes, hypertension and asthma. The initiative, part of the Yoga 365 campaign, seeks to...
Agentic AI Cuts Hospital Costs and Boosts Care Quality
From administrative work all the way up to clinical decision support, AI-enabled automation is changing the way hospitals operate. Great @EconomistImpact article here from @Oracle and @KPMG on how Agentic AI powered by robust data infrastructure can lower the cost...
Nanotechnology Sensor Reads Creatinine in Seconds for Rapid Kidney Testing
Researchers at Tohoku University and City College of New York unveiled a nanotechnology‑based creatinine biosensor that reads concentrations from 1 to 300 mg/dL in about 35 seconds. The device uses a platinum‑nanoparticle polymer composite tuned near the percolation threshold, eliminating the...
FDA Revises Recommendation on First Full Epcoritamab Dose in R/R DLBCL to Allow Outpatient Monitoring
The FDA has revised the label for epcoritamab (Epkinly) to permit outpatient monitoring of the first full 48‑mg dose in relapsed/refractory diffuse large B‑cell lymphoma (R/R DLBCL). The change follows interim EPCORE‑NHL‑6 data showing the dose can be safely administered...
Resistance Training Slows Biological Brain Aging in Seniors, Study Finds
Researchers at the Global Brain Health Institute reported that a year of heavy resistance training lowered the biological age of seniors' brains, as measured by advanced brain‑clock models. The randomized trial of 309 adults aged 62‑70 suggests weight lifting can...
Korsana Biosciences Announces Merger With Cyclerion Therapeutics, Concurrent $380 Million Private Financing
Korsana Biosciences announced a merger with Cyclerion Therapeutics, accompanied by a $380 million private placement. The financing round was led by Fairmount and Venrock Healthcare Capital, with participation from a slate of prominent venture and institutional investors. Cooley LLP represented the...
Healthcare Innovation Special Report: Post-Conference Intelligence — ViVE 2026
The Futurist Global released a post‑conference report on ViVE 2026, drawing insights from 28 top digital‑health leaders. It highlights that physicians access only 3‑5% of patient data, while hospital data volumes are doubling every two years to roughly 50 petabytes per...
AI Emerges as Healthcare Cornerstone, Validating Flexpa’s Vision
AI is firmly becoming a cornerstone of the healthcare system. when we founded @flexpa this was core to our bet. great to see.