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.

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.

Healthcare groups decry CDC messaging change on autism and vaccines

Mackenzie Bean / beckershospitalreview - Healthcare associations are raising concerns after the CDC this week removed messaging from its website stating that vaccines do not cause autism. The agency updated its webpage on vaccines and autism Nov. 19. Previously, the page said research has shown …

AI Summary: Recent modifications to the CDC’s online vaccine safety pages have alarmed healthcare groups, who contend that altered messaging risks bolstering discredited claims linking vaccines and autism. Critics warn that the move may destabilize public confidence in decades of robust, evidence‐based vaccine research.

Novo Nordisk rolls out lower prices for Ozempic and Wegovy

medicalxpress - People paying out of pocket for Ozempic or Wegovy may soon see lower costs, as Novo Nordisk rolls out new price discounts for its popular GLP-1 medications.

AI Summary: In a bid to ease the financial burden on self‐pay patients, Novo Nordisk has unveiled deep price cuts for its flagship GLP-1 drugs, Ozempic and Wegovy. The new pricing strategy comes amid intensifying market pressures and aims to broaden access to these critical therapies for weight management and type 2 diabetes.

Mikael Dolsten removes himself from board candidacy at Novo; Bavarian Nordic chairman resigns

Alex Hoffman / endpoints - → In what appears to be another blow to Novo Nordisk, ex-Pfizer CSO Mikael Dolsten has withdrawn his nomination to join the company's board of directors due to ...

AI Summary: Merck has made a blockbuster move by finalizing a $9.2 billion deal to acquire Cidara Therapeutics’ late‐stage anti‐influenza candidate. This acquisition underscores Merck’s commitment to expanding its antiviral portfolio and marks a key strategic investment in advancing flu prevention amid evolving global health threats.

F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause

Roni Caryn Rabin / nytimes - The benefits of hormone replacement have been underappreciated, Dr. Marty Makary, the agency’s commissioner, said on Monday. Critics described evidence for the change as insufficient.

AI Summary: In a bold policy pivot, the FDA will lift long‑standing black box warnings on hormone treatments for menopause. The decision – made without an official advisory committee’s input – updates labeling to better reflect current risk–benefit assessments, leaving critics to wonder if caution has finally given way to progress.

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

go - The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year

AI Summary: The FDA has revised the label for Sarepta’s Duchenne muscular dystrophy gene therapy, adding a boxed safety warning and stricter usage conditions following reports of two patient deaths. The update reflects mounting safety concerns that have prompted closer regulatory oversight.