GSK’s Hibsago brings a new mechanism of action to chronic hepatitis B, targeting the genetic instructions the virus uses to make copies of itself and viral proteins. This drug was licensed from antisense oligonucleotide specialist Ionis Pharmaceuticals. The post GSK Wins FDA Nod for Novel Hepatitis B Drug Offering a Potential Functional Cure appeared first on MedCity News.

As generative AI moves toward performing increasingly consequential clinical functions, the American Medical Association (AMA) is urging the U.S. Food and Drug Administration to address a foundational question: Who is responsible for ensuring that these tools remain safe once they enter clinical practice? The post AMA Calls for Risk-Based GenAI Oversight to Protect Patients and Support Responsible Innovation appeared first on MedCity News.

A patient’s automated risk score was reassuringly green. Pulling from a sparse medical record and infrequent acute visits, the model flagged him as low risk and routed him to the default, low-touch outpatient pathway — so why was the patient actively deteriorating? The post Your Product Works — So Why Does It Still Fail in the Real World? appeared first on MedCity News.

Rick Abramson, a radiologist by training and the director of FDA’s Digital Health Center of Excellence said, “We ended up putting out this idea that maybe these devices are starting to behave a little bit more like me as a physician than a heart valve or a defibrillator.” The post FDA Official Believes GenAI-enabled Tools Will Need to Be Assessed Like a Physician appeared first on MedCity News.

The Series A round was led by Define Ventures, with participation from Y Combinator and the California Health Care Foundation Innovation Fund. The post Readily Secures $11M for Compliance Intelligence Platform appeared first on MedCity News.

The GSK cancer immunotherapy Jemperli is now approved for treating advanced cases of rectal cancer harboring a particular genetic signature. It’s a label expansion for Jemperli, which was initially approved as a treatment for endometrial cancer. The post GSK Immunotherapy Gets Accelerated FDA Approval for Treating Rectal Cancer appeared first on MedCity News.

Cell and gene therapies are amazing medical breakthroughs but if we don’t find ways to pay for them, the development pipeline will fail. The post A Radical Proposal to Preserve Cell and Gene Therapy Innovation appeared first on MedCity News.

A new report on third quarter M&A activity in the healthcare sector found that this quarter’s hospital and health system transactions remained steady, with 2026 potentially set to be a top year for total annual transactions since pre-pandemic times. The post Report: Health System M&A Activity Remains Steady in Third Quarter appeared first on MedCity News.

AdvaMed CEO Scott Whitaker outlined four policy priorities at the MedTech Conference: tariffs, FDA user fees, payment and coverage, and cybersecurity. The post AdvaMed’s 4 Policy Priorities, According to Its CEO appeared first on MedCity News.

The Silence Therapeutics acquisition gives Merck KGaA a drug ready for a pivotal test in the blood disorder polycythemia vera. Silence’s RNA therapy offers a different approach and a potential dosing advantage over a Takeda Pharmaceutical product recently approved in this indication. The post Merck KGaA’s $1.1B Silence Therapeutics Buyout Brings RNA Drug for Rare Blood Cancer appeared first on MedCity News.

Phantom GI, a Tel Aviv-based medical startup, is developing the PercStoma device, a minimally invasive alternative to traditional ostomy surgery. The device would target patients with bowel obstructions who might otherwise be considered ineligible for surgery. The post With $5M, Phantom GI Plans to Develop Minimally Invasive Alternative Ostomy Surgery Device appeared first on MedCity News.

Some of the thorniest problems in medicine that AI can improve have nothing to do with diagnosis. They have to do with triage.  The post Diagnosis Is Beside the Point appeared first on MedCity News.

OMass’s molecule is vying to become an alternative to a Neurocrine Biosciences drug that is currently the only FDA-approved therapy for congenital adrenal hyperplasia. But Vertex Pharmaceuticals could also compete with a drug candidate from a recent acquisition. The post Startup OMass Secures $310M to Advance Drug for Rare Endocrine Disorder appeared first on MedCity News.

Allswell’s seed round was led by Rethink Impact, and included participation from Magnify Ventures, Ulu Ventures and Hopelab Ventures, joining existing investors Techstars and Amboy Street Ventures. The post Allswell Raises $7M to Grow LGBTQ+ Behavioral Health Platform appeared first on MedCity News.

This is not a discovery problem. It is a market entry and access problem, and it is far more tractable than the pipeline crisis we spend most of our attention on. The post The Antibiotics Exist —The System Cannot Deliver Them appeared first on MedCity News.