What's happening: FDA places 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 results 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:
Guernsey’s Data Protection Authority has sanctioned First Contact Health after a phishing attack compromised an employee’s email, exposing confidential patient data. The breach was discovered by the practice, which reported it to authorities, but regulators found the organization lacked adequate security controls such as multi-factor authentication. As a result, the DPA imposed a monetary penalty and mandated remedial measures. The incident underscores growing cyber risk in the healthcare sector.

Those “direct-to-physician” CDS AI tools like OpenEvidence and DoximityGPT? They're now going after health systems too. My 5 thoughts on how this will all play out: First, the gist of what was announced: → Sutter Health will integrate OpenEvidence with Epic, allowing...

The episode breaks down the release of the largest publicly available Medicaid claims dataset, detailing its composition, gaps, and immediate utility for health‑tech builders and investors. It quantifies the scale of Medicaid spending (~$849 B) and improper payments (over $30 B annually),...

KFF Health News experts appeared on multiple broadcast platforms in February, covering a range of pressing health topics. Elisabeth Rosenthal discussed soaring cancer‑care costs on ABC News Live, while Claudia Boyd‑Barrett highlighted families’ difficulty locating hospitalized ICE detainees on KQED’s...

Virginia’s emergency departments have seen a sharp increase in cannabis‑related visits, with overall cases climbing to an average of 31,000 per year between 2020 and 2024. Specifically, diagnoses of cannabis hyperemesis syndrome (CHS) jumped nearly 29%, rising from 4,027 cases...
We should have a class of drugs you can only sell to people over 70 —super aggro longevity stuff, muscle regeneration, etc - tolerate more possible bad side effects given you don’t have much time left for effects to manifest...
But this is such treachery. Doesn’t our govt understand pandemic threats? New waves of zoonotic flu, SARS-3 coronavirus; arboviruses from climate change; bioweapons from our enemies: Russia, DPRK, Iran; return of measles, pertussis, soon polio. What’s going on? Exclusive: Key US...

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has appointed FDA policy chief Grace Graham and senior FDA food official Kyle Diamantas as senior counselors who will also serve on his immediate staff. The move follows a broader senior‑level...

1. Time for a #flu & #measles update. Six more kids have died from flu, bringing the year-to-date total to 66. Sadly there will be more deaths reported but hopefully this year doesn't approach last year's dreadful pediatric death toll. #CDC...

More than 40 measles cases have been confirmed at Ave Maria University, marking the largest campus outbreak in recent memory. The incident follows similar exposures at Clemson, Anderson, the University of Wisconsin‑Madison and the University of Florida, indicating a broader resurgence....

In this live conversation, Dr. Bob Wachter and Dr. Lucy McBride discuss the fragmented state of electronic medical records (EMRs) and how patients and physicians alike are overwhelmed by multiple, non‑communicating digital portals. They highlight federal efforts to create standardized, interoperable...

CMS issued new guidance that widens the grandfathering window for Medicaid state‑directed payments (SDPs), allowing states to lock in higher rates through business‑day calculations. The expanded windows—Oct 11 2024 to July 3 2025 and July 7 2025 to March 27 2026—let providers preserve rates above the caps that...

Registered nurses and licensed staff at Providence Cedars‑Sinai Tarzana will begin a five‑day strike on Feb. 16, organized by SEIU Local 121RN, which represents more than 11,000 California healthcare workers. The union’s grievances include unsafe staffing levels, poor environmental conditions, workplace harassment,...

Green Lumber Holding, LLC issued a consumer alert after the FDA found undeclared tadalafil in products marketed as Green Lumber. The agency’s testing revealed that a former employee had diverted authentic packaging to distribute counterfeit, adulterated goods. Green Lumber confirmed...

Sabra Health Care REIT sold seven skilled‑nursing properties for $51 million in Q4, signaling a sharp pullback in nursing‑home M&A for 2026. The REIT’s pipeline will focus almost entirely on senior housing, which represents roughly 95% of its investment opportunities and...

Toronto‑based health‑tech startup Mesosil has secured FDA 510(k) clearance for its antimicrobial dental additive, allowing U.S. dental manufacturers to embed the technology in products such as composites and cements. The clearance follows a four‑year development program and validates the company’s...

WVU Medicine’s virtual ICU program, piloted at Potomac Valley Hospital, used daily remote rounds to connect critical‑care physicians with local staff, preventing patient transfers and boosting occupancy. The low‑cost model required roughly $5,400 in startup expenses and quickly raised daily...

Neil Huber founded Pulse Radiology Education in 2015 to give working radiologic technologists a flexible path to advanced certification. The company now operates two arms—Pulse Radiology Education and Pulse Radiology Institute—offering ARRT‑approved coursework, clinical placement, and an MRI associate degree....

University of Minnesota Physicians has appointed Dr. Greg Beilman, a critical‑care surgeon and retired Army Reserve colonel, as its permanent chief executive officer. Beilman, who served as interim CEO since July, will oversee the 4,500‑strong clinical enterprise and guide it...

Obesity has shifted from a behavioral label to a high‑growth biopharma arena, driven by breakthrough GLP‑1 drugs and emerging oral formulations. Stephen Hansen of BioCentury highlights how these agents mirror Type II diabetes treatments, creating a lucrative market and reshaping clinical...

Nektar Therapeutics announced robust Phase II results for its IL‑2R modulator rezpegaldesleukin in atopic dermatitis, propelling its stock 51% higher. Leveraging the momentum, the company closed an upsized $400 million PIPE financing consisting of common stock and pre‑funded warrants. Evommune also secured...
This was over two months ago at ASH, so ages, but here's how Disc's CEO said the bitopertin review was going back then. $IRON https://t.co/9SvSML6th8

Researchers at NIH and Emory have performed the world’s first minimally invasive coronary artery bypass, called VECTOR, without opening the chest. The technique reroutes blood flow by creating a new coronary ostium using catheter‑based tools introduced through the femoral vessels....

Researchers funded by the NIH discovered that satellite glial cells (SGCs) deliver mitochondria to sensory neurons through tunneling nanotubes, a process essential for neuronal energy supply. In mouse models of diabetes and chemotherapy‑induced neuropathy, this mitochondrial transfer is impaired, leading...

A new NIH‑funded study provides the strongest evidence linking severe chronic traumatic encephalopathy (CTE) to dementia risk. Analyzing 614 donated brains without Alzheimer’s or other common neurodegenerative diseases, researchers found stage IV CTE patients were 4.5 times more likely to have...

The National Institutes of Health halted the low‑dose rivaroxaban arm of the CAPTIVA trial after the Data Safety and Monitoring Board identified a rise in adverse events and concluded the treatment was unlikely to be beneficial. CAPTIVA, a double‑blind, three‑arm...

The National Institutes of Health has inaugurated the East Palestine Health Research Program Office, a five‑year, $10 million initiative to study the long‑term health impacts of the 2023 train derailment in Ohio. The office will coordinate community‑focused studies, enroll residents in...
The National Institutes of Health announced a Request for Information aimed at identifying biotechnologies that can replace human embryonic stem cells (hESCs) in research. NIH is temporarily pausing the review and approval of new hESC lines, leaving the existing 503...

A 20‑year NIH‑funded study of adults 65+ found that a brief, adaptive visual speed‑training regimen reduced Alzheimer’s and related dementia diagnoses by about 25% compared with memory or reasoning training. Participants completed 60‑75‑minute sessions twice weekly for five to six...

NIH researchers have built the first subcellular‑resolution digital twin of human retinal pigment epithelial (RPE) cells, using 3‑D imaging of 1.3 million cells and an AI algorithm called POLARIS. The model maps polarity, organelle size and volume across developmental stages, creating...

Oklahoma’s insurance commissioner announced that the state will abandon the federal health‑insurance marketplace and launch a decentralized, state‑run exchange beginning in the 2028 plan year. The new platform will rely on web‑based brokers to handle enrollment, giving the state greater...
FDA rejects rare disease therapy from $IRON Disc Medicine, early recipient of commissioner’s voucher CNPV program falters out of the starting gate... https://t.co/w4ptB2ecRS via @LizzyLaw_ and me

The FDA rejected bitopertin, Disc Medicine’s experimental therapy for acute hepatic porphyria, marking the first drug reviewed under Commissioner Marty Makary’s fast‑track voucher program. The agency cited uncertainties about the link between the trial’s blood‑based biomarker and actual clinical benefit....

South Carolina’s measles outbreak has surged to 933 confirmed cases as of Feb 10, according to the state Department of Public Health. Unvaccinated individuals account for 859 of those infections, underscoring a vaccination gap. The outbreak follows a steady climb from...

A Canadian study of 343 patients with moderate or severe aortic stenosis found that automated prompts in echocardiography reports and EMRs only modestly improved specialist referrals. About 60% of severe AS patients and just over 20% of moderate cases were...

The U.S. Department of Health and Human Services issued a request for information on a proposed 340B rebate model pilot, inviting comments through March 19. The Health Resources and Services Administration’s Office of Pharmacy Affairs will use stakeholder feedback to decide...

In February 2026 the American College of Physicians (ACP) released a policy paper in Annals of Internal Medicine urging that doctors be called physicians, not “providers.” The ACP argues the term provider, rooted in 1965 Medicare language, dilutes medical professionalism...

#NIH to deprioritize pandemic preparedness and biodefense research, @nature.com reports, saying director Jay Bhattacharya wants to focus on known diseases, not possible future threats. What could possibly go wrong? https://t.co/6TpLr6pY3B https://t.co/7rVzvkOzkT

A healthy diet, accounting for longevity-related genes, associated with 2-3 more years of life expectancy from >100,000 people followed 10.6 years, max benefit for starting at youngest age (Figure) @uk_biobank @ScienceAdvances https://t.co/Ji7Wlhj9ZA https://t.co/B6UxuE97xG

The episode explains InterSystems' new Payer Connector, clarifying that it is not a rival to Epic's Payer Platform but a complementary integration layer that helps payers connect Epic's standardized edge to their fragmented internal systems. It highlights the challenges payers...

On February 12, a U.S. District Court in Texas vacated the Federal Trade Commission’s final rule that altered pre‑merger notification requirements under the Hart‑Scott‑Rodino Act. The rule had expanded the HSR filing form and imposed additional reporting obligations on merging firms....
Open enrollment for the Affordable Care Act closed in February, revealing the first impact of the December 31, 2025 expiration of enhanced premium subsidies. While total sign‑ups exceeded some analysts' forecasts, enrollment was still 1.2 million lower than the same period...

A new report from the Center for Innovation & Value Research quantifies caregiver stress as a massive economic driver, estimating $14.1 trillion in annual U.S. costs. Interviews with 55 workshop participants reveal that chronic stress leads to work disruption, higher household...

A randomized trial of 347 adult survivors of childhood cancer found that early cardiovascular (CV) risk screening alone was as effective as screening plus one‑on‑one counseling. Both groups showed improvements in blood pressure and lipid measures, with the counseling arm...
In a HealthLeaders podcast, Muhammed Chebli, NextGen Healthcare’s vice president of product, interoperability, explains how health systems can convert data exchange initiatives into measurable business value. He outlines concrete methods for linking interoperability to revenue‑cycle efficiency, claim‑denial reduction, and faster...

The FDA outlines its compounding program, which permits licensed pharmacists or physicians to mix, combine, or alter drug ingredients to meet individual patient needs. Compounded medications are not FDA‑approved, meaning they bypass pre‑market safety and efficacy review. The agency’s oversight...
The episode reviews recent CDC press releases, highlighting a series of Salmonella outbreaks tied to moringa leaf powder and other dietary supplements, as well as raw oysters. It also notes the launch of the nation’s largest National Firefighter Registry for...
On February 17, 2026, HIMSS will host a 30‑minute panel featuring IBM Consulting’s Cathy Reese and Snowflake’s Jesse Cugliotta to explore the intersection of interoperability and artificial intelligence in healthcare. The discussion will assess current AI maturity, outline best practices for constructing...

The FDA issued a warning letter to MKS Enterprise, LLC after laboratory analysis revealed that its product Vital Honey contained the prescription drug tadalafil, an undeclared active pharmaceutical ingredient. The agency determined the honey is both a prohibited food adulterated...