Replimune went from an FDA rejection to a resubmission, a positive advisory committee vote, and finally an accelerated regulatory approval for advanced melanoma — all in less than four months. The FDA nod for Replimune’s oncolytic viral therapy, Tudriqev, positions it as a more convenient alternative to an Iovance Biotherapeutics cell therapy that had been the only treatment in this setting. The post Recovery for Replimune: Accelerated Approval for Cancer Drug Twice Spurned by FDA appeared first on MedCity News.

Democratic senators are urging CMS to withdraw its Medicaid work requirements rule, arguing it will create administrative burdens and cause eligible beneficiaries to lose coverage. The post Democratic Senators Urge Withdrawal of Interim Final Rule on Medicaid Work Requirements appeared first on MedCity News.

Historically, prevention has focused on protecting teeth from decay and gum disease. However, long-term oral health is also shaped by how the teeth, muscles, and jaw function together over time. The post The Missing Piece of Preventive Dental Care Lies in the Bite appeared first on MedCity News.

Gaps in prevention are not frequently due to a complete lack of information, but instead the fact that organizations don’t have a clear way to see how the pieces fit together until after an incident has occurred. The post Healthcare Workplace Violence Prevention Needs Better Visibility Into Risk Signals appeared first on MedCity News.

Scheduled for October 29 at Pegasus Park in Dallas, the theme of the INVEST Digital Health conference will be consumers in healthcare from d2c diagnostics to GLP-1 drugs and wearables. Register today! The post INVEST Digital Health Conference Returns with Focus on Consumers appeared first on MedCity News.

The FDA approved Moderna’s flu vaccine mFLUSIVA, a regulatory decision that comes six months after the agency refused to review the mRNA shot and then quickly reversed its position. But a recommendation from a Centers for Disease Control and Prevention advisory committee is key for payer coverage, and that committee has not met all year due to ongoing litigation. The post Moderna Gets FDA Approval for mRNA Flu Vaccine, But CDC Input Still Uncertain appeared first on MedCity News.

A new survey found that many employers are considering ICHRAs, though concerns about awareness, affordability and the individual insurance market continue to slow adoption. The post Report: What Employers Think About ICHRAs appeared first on MedCity News.

At MedCity News’ inaugural Bullseye conference in Chicago, Debunked Podcast co-hosts Arundhati Parmar and Samir Batra discussed recent CMS actions and Mayo Clinic’s former research director, who has filed a complaint against the medical center over how it’s deploying AI. The post Debunked Episode 29: CMS GLP-1 Drug Pilot Program, RPM Strategy Raise Questions appeared first on MedCity News.

The industry has made real progress in recognizing that oral health belongs at the center of whole-person care, but intent alone isn’t enough. To translate this vision into something tangible, the industry must invest in infrastructure that makes integration not only possible but scalable. The post Connecting the Dots: How Oral Health Can Enable Whole-Person Care  appeared first on MedCity News.

Cold chain is a logistics problem — not just a throughput problem. Pharmacies must rethink their strategy, not just automate it.  The post Should You Centralize Cold Chain Fulfillment? Only If You’ve Solved Distribution First appeared first on MedCity News.

UnityPoint Health’s chief medical officer, Gregory Johnson, shared several ways the system is using AI to lift administrative burden off clinicians and get them back to patient care — including ambient scribing, real-time capacity tracking and AI-powered chart review. The post 6 Ways UnityPoint Health Is Trying to Make Clinicians’ Jobs Easier appeared first on MedCity News.

Curative Insurance Company partnered with Wondr Health to expand weight management support for its members. The post Curative, Wondr Health Team Up for Weight and Metabolic Health Support appeared first on MedCity News.

Attovia Therapeutics’ biologic medicines could offer advantages over currently available immune disorder drugs, such as Sanofi’s blockbuster medicine Dupixent. The IPO comes as Attovia looks to expand clinical development of its pipeline in 2027. The post Attovia’s Upsized IPO Brings In $289M to Fund New Kind of Biologic for Immune Disorders appeared first on MedCity News.

Despite the silk masks, oils, and sleepy girl mocktails swirling around social media, one of the greatest causes of non-restorative sleep is rarely mentioned by wellness influencers online: actual sleep disorders. The post The Sleep Crisis We May Be Missing: Why Millions of Americans Remain Undiagnosed  appeared first on MedCity News.

Healthcare leaders who shape that future need more than innovation. They need a visible, credible voice that helps the people around them — patients, clinicians, employees, partners, and investors — understand what the change is, why it matters, and why this is the right person to lead it. The post The Healthcare Leaders Driving Change Need to Get Better at Explaining It appeared first on MedCity News.