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:

The BioCentury This Week podcast highlighted the rapid expansion of oral selective estrogen receptor degraders (SERDs) as a leading application of targeted protein degradation, noting several candidates advancing toward late‑stage trials. Host Lauren Martz examined the competitive landscape and the therapeutic promise for hormone‑responsive cancers. The episode also covered recent FDA setbacks affecting Disc Medicine’s orphan therapy and Moderna’s vaccine, sparking debate over regulatory oversight. Washington editor Steve Usdin called on industry leaders to demand the dismissal of FDA CBER chief Vinay Prasad.

The Centers for Medicare & Medicaid Services (CMS) is expanding its hybrid quality‑measure (QM) methodology, merging Minimum Data Set (MDS) information with Medicare claims to improve accuracy. Recent OIG reports on antipsychotic medication use and falls with major injury prompted...

Virginia lawmakers are debating a suite of bills aimed at improving nursing home oversight, staffing, and transparency. One proposal sets minimum nursing care hours at 3.08 per resident per day through 2027, rising to 3.25 by 2031 for facilities in...

A federal judge is set to rule this week on a lawsuit seeking to prevent the CDC’s Advisory Committee on Immunization Practices (ACIP) from convening. The plaintiffs argue the committee, whose members were appointed by HHS Secretary Robert F. Kennedy...

Hospital groups warn that expanding site‑neutral Medicare payment could slash revenues by $182 billion over the next decade, with rural facilities facing a $26.3 billion hit. The FTI Consulting report, commissioned by the Coalition to Strengthen America’s Healthcare, projects an 8% cut...

Physicians, medical educators and health system leaders testified before the Senate Special Committee on Aging that escalating CMS regulations—particularly prior authorizations and Medicare quality reporting—are intensifying burnout and prompting many to leave clinical practice. The testimony highlighted that these administrative...

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...

A machine‑learning model that combines cardiac MRI data with clinical variables predicts long‑term major adverse cardiovascular events (MACE) in STEMI patients more accurately than the GRACE and TIMI scores. The study analyzed 1,066 patients, training on 682 cases and testing...
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 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...

Gilead Sciences has agreed to pay $80 million upfront to Suzhou Genhouse Bio for worldwide rights to GH31, a clinic‑ready oncology molecule. GH31 employs synthetic lethality to inhibit the MAT2A enzyme, a target implicated in several cancers. The deal follows regulatory...
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...
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...
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...

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,...
The FDA granted accelerated approval to sibeprenlimab‑szsi (Voyxact) for primary IgA nephropathy, marking the first APRIL‑inhibiting monoclonal antibody for this condition. Interim results from the phase 3 VISIONARY trial showed a 50 % reduction in proteinuria at nine months versus 2 % with...
AdventHealth President and CEO David Banks will deliver the opening keynote at HIMSS26’s Executive Summit in Las Vegas, titled “Leading Through Healthcare’s Perfect Storm.” He will frame the current systemic headwinds as an opportunity to shift from episodic, diagnosis‑centric care to...

Healthcare faces a looming shortage of over 63,000 full‑time registered nurses by 2030, intensifying pressure on existing staff. Manual tasks such as charting and medication administration divert nurses from bedside care, prompting a push for smarter automation. Omnicell’s new Titan...

Healthcare leaders traditionally separate emotion from decision‑making, but a recent hospital closure in New York demonstrates that compassionate leadership can coexist with operational rigor. The tertiary medical center reduced from 700 to 200 beds, faced financial loss, and ultimately closed...

Federal policies driven by Health Secretary Robert F. Kennedy Jr. are creating a hostile environment for vaccine developers, prompting companies like Moderna to scale back late‑stage studies. A Texas startup canceled a new manufacturing plant, and a San Diego firm...
Medicare Advantage insurers are confronting a perfect storm of rising medical costs and a flat payment increase of less than 1% announced by CMS for 2026. The new risk‑adjustment formula and stagnant reimbursement fall below the medical‑cost trend, compressing margins...

Dr. Mehmet Oz, CMS administrator, advocated AI avatars as the most effective solution to bridge mental‑health gaps in rural America. He highlighted the chronic shortage of clinicians and argued that agentic AI can conduct early intakes, detect subtle speech cues,...