What's happening: FDA puts Regeneron's anti‑activin A antibody garetosmab under priority review
The agency has granted priority review to Regeneron's garetosmab for the rare disease fibrodysplasia ossificans progressiva, with a decision expected by August. Phase 3 OPTIMA data showed a 94% reduction in new heterotopic ossification lesions at the lower dose and a 90% reduction at the higher dose, alongside a >99% drop in lesion volume.
Also developing:
Immedica’s pegzilarginase (Loargys), the first enzyme replacement therapy for arginase‑1 (ARG1) deficiency, has received NICE endorsement for NHS use in the UK. The weekly IV or subcutaneous treatment cuts blood arginine levels by roughly 80% and is recommended for patients aged two and older. The ultra‑rare disorder, affecting about 20 people in England, currently relies on strict diet and ammonia‑lowering drugs. Loargys carries a list price of £4,690 per vial, translating to roughly £33,000 annually before a confidential discount.
A “Variant of Unknown Significance” is a genetic finding that can’t yet be interpreted, leaving families with uncertainty instead of answers. Now, AI agents can help connect sequencing data with scientific literature and biological context to turn VUS into traceable, evidence-backed...
The UK government, via Innovate UK, has launched a £20 million funding programme to accelerate development of medicines, medical devices, wearables, virtual‑reality therapies and AI‑enabled tools for drug and alcohol addiction. Grants of up to £10 million for late‑stage projects and up to...

Barcelona is emerging as a premier European life‑sciences hub, contributing 7.6 % of Catalonia’s GDP and ranking sixth in scientific output. Six local biotech firms—Accure Therapeutics, Oryzon Genomics, SpliceBio, Peptomyc, Ona Therapeutics and Integra Therapeutics—are advancing diverse modalities from small‑molecule neuroprotectors...

Orthalis, backed by private equity firm Extens, announced the acquisition of Dentalsoft, a specialist orthodontic software provider. The purchase creates a new entity, SignalSoft Développement, focused on delivering software services to orthodontic professionals. By integrating Dentalsoft’s tools, Orthalis expands its...
Researchers at KAIST unveiled an AI‑driven method that extracts wavelength‑dependent information from standard optical coherence tomography (OCT) to automatically detect lipid‑rich coronary plaques. The weakly supervised deep‑learning model learns from frame‑level labels, eliminating the need for pixel‑wise annotations and works...
Researchers at Texas A&M have created injectable nanocomposite hemostats that cut blood clotting time from six‑seven minutes to one‑two minutes, slashing bleeding duration by up to 70% in internal hemorrhage models. The devices combine clay‑derived nanosilicates with a shape‑memory foam...
UCLA researchers have engineered lipid nanoparticles to co‑deliver CRISPR/Cas9 components and a full‑length CFTR gene, achieving precise, mutation‑agnostic insertion in human airway cells. The non‑viral system corrected 3‑4% of cells yet restored up to 100% of normal chloride channel function,...
Researchers at St. Jude Children’s Research Hospital introduced M‑PACT, an AI‑driven liquid‑biopsy platform that classifies pediatric brain tumors from cerebrospinal fluid with 92% accuracy. The deep neural network was trained on over 5,000 DNA methylation profiles covering about 100 tumor...

Kipu Health announced Elevate 2026, a three‑day customer conference in Carlsbad, California, showcasing its AI‑native Kipu Helix Intelligent Operating System for behavioral health. The event gathers executives, operators and administrators to explore AI‑driven strategies, hands‑on programming and peer insights. Kipu...
This is the kind of AI that moves me. After 18 years of silence, Ann spoke again. A brain implant reads signals from her speech cortex. AI decodes them in real time. A digital avatar restores her voice and facial expressions. What’s new? Not text on...
Regulatory uncertainty is rising as the FDA shifts leadership, adopts a single‑trial approval pathway, and tightens its benefit‑risk framework. While the one‑trial standard promises faster, cheaper market entry, recent surprise complete response letters (CRLs) show that even successful Phase 3 results...
Ionis Therapeutics announced that its GSK‑partnered antisense drug bepirovirsen achieved a statistically significant functional cure rate of roughly 15‑20% in a Phase 3 trial, far surpassing the 1‑3% rate of existing hepatitis B therapies. The company also reported a strong first‑year launch...
A new analysis in Health Affairs Scholar reveals that brand‑name drugmakers are exploiting the Hatch‑Waxman framework through serial patent litigation and continuation patents to extend market exclusivity. By filing multiple overlapping patents, companies can repeatedly sue generic challengers, triggering 30‑month...

Resveratrol protects kidneys from fat accumulation and diabetic kidney disease by activating SIRT1, similar to its effects on fatty liver 🐁 www.sciencedirect.com/science/article/abs/pii/S1098882326000067
AI medical advice: Not ready for prime time. A study by the Icahn School of Medicine at Mount Sinai, published in The Lancet Digital Health, reveals vulnerabilities in medical AI systems. https://t.co/ArD323yhzL #research #AI #healthcare #medicine
The 2025 review in *Microsystems & Nanoengineering* details how photonic noses combine optical sensing with AI to create highly selective, drift‑free chemical detectors. By leveraging colorimetric, refractive‑index, absorption and spectroscopy techniques, these devices generate rich spectral fingerprints that machine‑learning models...
RFK Jr. has long criticized pharma's influence on the federal government. But Dr. Oz, talking to PhRMA today, took a different approach: welcoming the idea of closed-door meetings and urging industry leaders to work in the administration. w/ @LizzyLaw_ https://t.co/xZUFKVKRdJ

This is a big deal. Since 1958, the FDA has allowed food companies to self-certify ingredients as "Generally Recognized As Safe" (GRAS). In comparison Europe only allows ~400 such additives to their foods. In the US there are 4,000–10,000 ingredients that are added...
Researchers at Southern University of Science and Technology have unveiled an optoelectrowetting platform that uses programmable light patterns to dispense nanoliter droplets with unprecedented precision. By projecting dynamic illumination onto a microfluidic chip, the system creates virtual electrodes that guide...
The article highlights hidden insurance risk from undertrained nursing assistants and home caregivers, linking credential gaps to higher workers' compensation, liability, and long‑term care costs. It argues insurers should treat frontline training as loss‑mitigation, incentivizing certifications and first‑aid programs. By...
What if your wheelchair could map your house and drive you to specific spots on command? Strutt's EV1 does exactly that. It learns your space, lets you save waypoints, and navigates at 3 mph while avoiding obstacles. Manual override is...

Dr. Jesse M. Ehrenfeld, former AMA president and global CMO of Aidoc, opened HIMSS26’s Physicians’ Forum with a keynote titled “From Hype to Healing: Real‑World AI Integration in Clinical Practice.” He warned that clinicians are overwhelmed and that AI must...
Medtronic performed the first U.S. Hugo robotic surgery—a prostatectomy at the Cleveland Clinic—shortly after receiving FDA clearance. The system, already CE‑marked in Europe, is being installed at Duke University Hospital and Atrium Health, marking its initial U.S. footprint. CEO Geoff...
The next decade is the brain health decade, as I discussed with Bristol Myers Squibb (@bmsnews) CEO Chris Boerner at their Global Town Hall last week when @Thrive Global launched our brain health partnership to their 34,000 employees. BMS is...
You can just take a picture of your medical data or upload the file to get a second opinion from Grok

Epic’s analysis of 411 million primary‑care visits shows telehealth usage has plateaued at roughly 6‑7 % of appointments since mid‑2023, following the pandemic‑driven surge. The share remains highest in metropolitan areas, with lower adoption in micropolitan, rural and small‑town settings. Adults aged...

With all the attention on China for TOPO-I ADCs of late, how about the potential for European agents, especially ones involving novel targets? Our latest expert interview drops with some hard hitting and candid opinions from a battle hardened...

Fitch downgraded John Fitzgibbon Memorial Hospital in Marshall, Missouri to a “D” rating from “C” and withdrew its issuer and bond ratings after the hospital defaulted on required debt payments. The default concerns principal and interest on 2010 bonds, and...

Marshfield Clinic will open its 13th hospital on March 1 in Wisconsin Rapids, adding a full‑service acute‑care facility to the existing Marshfield Clinic Wisconsin Rapids Center. The new campus features inpatient beds, an emergency department, advanced imaging such as CT...

Cleveland Clinic became the first U.S. health system to perform a robotic‑assisted prostatectomy using the newly FDA‑cleared Hugo RAS system. The robot, approved in December, features modular arms and an open‑console that surgeons control with foot pedals and hand inputs....

The care economy’s expansion has attracted a sophisticated, global fraud network that stole nearly $4.9 billion from older Americans in 2024, a three‑fold rise over five years. Scammers now run multi‑stage attacks that blend tech‑support ruses, fake bank officials, and crypto...

On Feb. 4, a fire engulfed the Orthopedic Institute building at Jefferson Health’s Lehigh Valley Hospital‑Dickson City, prompting the evacuation of more than 70 patients. Thanks to extensive disaster training and coordinated effort among staff, first responders, and local partners, no...

Thomas Jefferson University, owner of Jefferson Health, posted a $201 million operating loss for the first half of fiscal 2026, reflecting a -2.3% operating margin. The loss includes $64.7 million in restructuring expenses tied to a planned layoff of roughly 650 employees....

The U.S. Food and Drug Administration issued Warning Letter 320‑26‑43 to Cosmetic Manufacturers Pty Ltd., citing extensive Current Good Manufacturing Practice (CGMP) violations across laboratory testing, process control, equipment qualification, and written procedures. The agency placed the firm on Import...

The FDA’s Office of Generic Drugs has launched a public, bi‑weekly list of all approved abbreviated new drug applications (ANDAs) that carry a Competitive Generic Therapy (CGT) designation. The list details each product’s reference listed drug, NDA number, applicant, active...

Never‑smokers now account for 10‑20% of U.S. lung‑cancer cases, a share that is climbing despite overall declines. Current USPSTF guidelines limit low‑dose CT screening to heavy‑smoking adults, leaving most never‑smokers unscreened. Shira Boehler’s incidental finding on a whole‑body MRI prompted...

A large Swedish cohort study of 2.7 million children tracked over 35 years shows that while boys are diagnosed more often in childhood, the male‑to‑female autism ratio narrows to about 1.2 by age 20 and may reach parity in adulthood. The...

Dr. Ronald L. Lindsay recounts how he built a fully operational pediatric medical home at a regional military hospital in just two and a half years, delivering 24/7 care to vulnerable children from worldwide military families. His interdisciplinary developmental‑behavioral clinic...
Developers of cell and gene therapies must choose between fully integrated turnkey platforms and modular, multi‑device systems. Integrated solutions deliver rapid time‑to‑value and simplified workflows, ideal for low‑volume autologous products, but they restrict reagent flexibility and scale. Modular platforms provide...
The pharmaceutical industry now invests over $5 billion annually in patient support programs (PSPs), which boost adherence by roughly 30 % and lower overall healthcare costs. Diagnostic laboratory testing is a cornerstone of these programs, delivering timely data that guides dosing, monitors...

Danaher, a US healthcare conglomerate, is close to finalizing a roughly $10 billion acquisition of Masimo, the maker of pulse‑oximetry and other medical monitoring devices. The deal, still subject to antitrust clearance, would add Masimo’s sensor technology to Danaher’s Life Sciences...
Biopharma faces a tightening fetal bovine serum (FBS) market as U.S. cattle inventories hit record lows and European disease outbreaks curb supply. Prices have surged more than 300% over five years and release timelines have lengthened from weeks to months...

What if a physician could inject you with a plasmid that would induce an immune response against a protein needed for cancer cell survival? This novel strategy is being tested and looks promising for refractory cancers. Talking Biotech 488 ...
Livingston HealthCare in Montana announced that its phone system has been fully restored after a recent cybersecurity incident forced the hospital to shut down communications and other network services. The disruption, first reported on Feb. 13, stemmed from a potential...
HFMA’s FastFinance podcast highlights new off‑campus HOPD reporting requirements that could impose significant cost burdens on health systems. The episode also cites a "Weird Number"—a 3‑5% annual net revenue loss attributed to inefficient electronic health records and billing platforms. Additionally,...

Smart hospital rooms equipped with interactive displays, sensors, and AI are moving from pilot projects to core infrastructure in new builds and retrofits. The global market, valued at $67 billion in 2024, is expected to nearly triple by 2030 as health...
Effective Jan. 1 2028, the Consolidated Appropriations Act of 2026 requires hospitals to assign separate NPIs and submit two provider‑based attestations for each off‑campus hospital outpatient department (HOPD) or lose Medicare OPPS reimbursement. Compliance documentation can be extensive—up to 200 pages per...
Researchers at Shanghai Jiao Tong University engineered a lipid nanoparticle (LNP) formulation that delivers therapeutic mRNA directly to spermatocytes in mice. By injecting mRNA encoding the wild‑type Msh5 gene, they transiently restored meiosis in mice with a genetic block, achieving...
Dr. Michael Spaeder will present at HIMSS26 on using AI‑enabled analysis of continuous bedside cardiorespiratory monitoring to detect patient deterioration earlier than traditional electronic health record methods. He will contrast predictive insights from live physiologic data with retrospective EHR analytics,...