California Discourages Wild Mushroom Foraging After Fatal Outbreak

Hannah Ziegler / nytimes - Officials said one person was killed and 20 others were poisoned after eating death cap mushrooms, which look and taste like safe mushrooms but can cause liver failure.

AI Summary: California health officials report that a deadly outbreak—killing one person and poisoning 20 others after death cap mushrooms were mistaken for edible varieties—has forced officials to warn the public against wild mushroom foraging. The state identified 21 poisoning cases, leaving foragers with a grim reminder to stick to their grocery store mushrooms.

Startup Protego Bio Lands $130M for First-in-Class Drug’s Pivotal Test in Rare Plasma Disorder

Frank Vinluan / medcitynews - Protego Biopharma’s lead program is a potential treatment for the rare disease light chain amyloidosis. The startup says the novel mechanism of its oral small molecule should have better outcomes than antibodies from AstraZeneca and Prothena that failed t…

AI Summary: Two reports reveal that Protego Bio has raised $130M to fund pivotal clinical testing of its novel therapy for AL amyloidosis, a rare plasma disorder. This funding milestone, backed by industry leaders, marks a significant advance in treatment options for a challenging condition.

ACIP drops universal hepatitis B birth dose recommendation

Max Bayer / endpoints - A panel of CDC vaccine advisors has stopped recommending that all children receive the hepatitis B vaccine at birth, overruling scientific consensus and public health officials who pleaded that there was no grounded rationale for ...

AI Summary: A panel of CDC vaccine advisors has upended decades‑old practice by halting the universal administration of hepatitis B vaccine at birth. Citing evolving scientific evidence, the change aims to more precisely target high‑risk infants and re‐calibrate newborn immunization protocols, representing a significant policy pivot in pediatric healthcare.

A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes

fiercehealthcare - Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the agency.

AI Summary: A dozen former FDA commissioners have fiercely criticized the proposed overhaul of U.S. vaccine regulations spearheaded by FDA official Vinay Prasad, warning it could undermine decades‐old safety standards and erode public trust in immunization.

UK and US agree zero-tariff deal on pharmaceuticals

go - Officials say the U.K. has sealed a deal securing a 0% tariff rate for all U.K. medicines exported to the U.S. for at least 3 years, in return for the U.K. spending more on new medicines

AI Summary: In a twist worthy of a Hollywood trade drama, officials announced that the UK and US have struck a deal to impose zero tariffs on UK‐made medicines destined for the US. As part of the arrangement, the UK must shell out considerably more for drug pricing—a move set to avoid tariffs that could soar as high as 100%—with the agreement effective for at least three years.

FDA approves all ages gene therapy for spinal condition

Ella Jeffries / beckershospitalreview - The FDA approved Novartis’ Itvisma (onasemnogene abeparvovec-brve), the company’s first and only gene replacement therapy for spinal muscular atrophy in children 2 and older, as well as for teens and adults. The therapy is designed to address the genetic …

AI Summary: The FDA has given the green light to Novartis’ gene replacement therapy Itvisma for the treatment of spinal muscular atrophy, a development that extends its use to patients of all ages. The approval, which responds to long‐standing concerns over safety and patient eligibility, marks a significant milestone in SMA care.

Novo submits high-dose Wegovy for FDA approval using voucher

Max Bayer / endpoints - Novo Nordisk submitted a higher dose of its obesity drug Wegovy for FDA approval and is using a recently-won voucher to expedite the review. The company said Wednesday that it submitted ...

AI Summary: Novo Nordisk has formally submitted its application to the FDA to approve a higher-dose formulation of its flagship obesity drug, Wegovy. Leveraging a recently secured priority voucher, the filing is set to potentially expand treatment options for weight management as the review process begins.

CASSANDRA-PACT-21 Trial Update: Preoperative PAXG vs mFOLFIRINOX in Resectable and Borderline Resectable PDAC

oncodaily - The landscape of early-stage pancreatic ductal adenocarcinoma (PDAC) continues to evolve as clinicians move from surgery-first strategies toward perioperative treatment. Neoadjuvant and perioperative approaches have shown growing promise, yet no […]

AI Summary: New findings from the CASSANDRA study indicate that a neoadjuvant quadruplet PAXG regimen significantly improves event‐free survival versus traditional mFOLFIRINOX in patients with resectable or borderline resectable pancreatic ductal adenocarcinoma, suggesting a potential shift in treatment guidelines.

Tracking with care: The ethics of using location tracking technology with people living with dementia

medicalxpress - Imagine you're 83 years old, living with dementia in a long-term care home. Lately, your caregivers keep asking you to wear a bracelet on your wrist 24/7. They say it's for your safety, so they can locate you quickly when needed.

AI Summary: As care providers turn to real‐time tracking devices for people with dementia, questions of privacy versus safety now dominate the debate. Critics contend that constant monitoring can undermine personal autonomy, while proponents emphasize its potential to prevent emergencies. The discussion highlights the ethical balance between protection and individual dignity.

Novo Nordisk GLP-1 fails to slow Alzheimer’s in trials

Ella Jeffries / beckershospitalreview - Novo Nordisk’s GLP-1 drug semaglutide did not demonstrate a statistically significant effect in slowing progression of Alzheimer’s disease in two late-stage clinical trials. According to a Nov. 24 news release from the company, two double-blinded, placebo…

AI Summary: Novo Nordisk’s much‑talked‑about GLP‑1 drug, famed for its weight‐loss benefits, has hit an unexpected wall in Alzheimer’s trials. In two separate reports – one on the standard injectable and another on a pill form – semaglutide showed no statistically significant impact on slowing brain decline. Who knew obesity meds couldn’t multitask?

FDA Approves Pembrolizumab + Enfortumab Vedotin-ejfv for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

oncodaily - What Does FDA Approval Mean? The U.S. Food and Drug Administration (FDA) evaluates new cancer therapies to determine whether they are safe and effective for clinical use. Approval is based […]

AI Summary: The U.S. Food and Drug Administration has approved a combination of pembrolizumab (Keytruda) and enfortumab vedotin (Padcev) for patients with muscle‐invasive bladder cancer who cannot tolerate cisplatin. Both agents—which have individually transformed treatment paradigms—are now linked in a perioperative setting that could alter outcomes for this aggressive cancer.

New nasal nanodrops wipe out brain tumors in mice

sciencedaily - A new nasal-delivered nanotherapy shows promise against aggressive glioblastoma tumors. By activating the STING immune pathway using gold-core spherical nucleic acids, researchers were able to reach the brain without invasive surgery. When paired with dru…

AI Summary: A novel nasal‐delivered nanotherapy that triggers the STING immune pathway via gold‐core nanoparticles has been shown in mice to nearly wipe out aggressive brain tumors. This noninvasive approach offers hope for a radically new treatment modality in glioblastoma.

Medicare premiums set to rise 10% next year, CMS says

Rebecca Pifer / healthcaredive - The Part B premium hike could have been worse, the Trump administration said. Still, it’s likely to pressure the pocketbooks of millions of seniors, and could drive more into Medicare Advantage plans.

AI Summary: CMS has announced that Medicare Part B premiums will jump by 10% next year—a move that will affect millions of enrollees. With these new cost pressures hitting an already strained budget environment, experts warn beneficiaries should brace for a challenging financial landscape moving forward.

FDA Approves Ziftomenib for Relapsed or Refractory Acute Myeloid Leukaemia with a NPM1 Mutation

esmo - Evidence for efficacy is based on the results from the KO-MEN-001 study

AI Summary: The FDA has granted full approval for ziftomenib—a novel agent aimed at treating relapsed or refractory acute myeloid leukemia, especially in patients with NPM1 mutations. Backed by the KO‐MEN‐001 trial data, this decision marks a significant step forward for a patient group in dire need of new therapeutic options.

New Flu Strain and Low Vaccination Rates Could Mean Aggressive Flu Season Ahead

discovermagazine - Starting in 2025, this year’s flu season is spreading early, and with vaccination rates low and a novel virus strain, health experts are warning that it could be a rough one.

AI Summary: Early indicators for this year’s U.S. flu season reveal a paradox—while overall flu activity remains low, the emergence of a new virus strain combined with declining vaccination rates is prompting health experts to warn of a potentially aggressive surge later in the season. Immediate vigilance and ramped‐up vaccination are urged.

CMS issues new telehealth guidance: 4 notes

Giles Bruce / beckershospitalreview - CMS has released updated telehealth guidance following the end of the 43-day government shutdown. Here are four things to know from the November FAQ: 1. CMS will retroactively pay for telehealth claims for services rendered amid the fiscal standoff. 2. Me…

AI Summary: The Centers for Medicare & Medicaid Services has released new telehealth guidance in the wake of the government shutdown. The updated policy clarifies claim submissions and resolves technical issues to better accommodate providers’ needs as they pivot to remote care.

CMS ups hospital outpatient rates 2.6%, expands site-neutral payments in 2026: 14 notes

Alan Condon / beckershospitalreview - CMS on Nov. 21 finalized its Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System rule for 2026, enacting reforms to boost price transparency and expand outpatient access. Fourteen things to know: Hospital outpatien…

AI Summary: CMS has finalized a rule that increases reimbursements to hospital outpatient centers and ambulatory surgical centers by 2.6%, and expands site‐neutral payment policies set for 2026. The move is aimed at aligning provider payments with rising costs amidst evolving care delivery models.

WHO declares end of Indonesia's poliovirus outbreak following yearslong vaccination campaign

medicalxpress - The World Health Organization has declared Indonesia's polio outbreak officially over, following nearly three years of intensive response efforts, officials said Friday.

AI Summary: The World Health Organization has officially declared Indonesia’s poliovirus outbreak over after nearly three years of intensive vaccination campaigns and public health efforts. Officials emphasize that sustained immunisation and surveillance remain essential to preserve this hard‐won success.