United States: Food, Drugs, Healthcare, Life Sciences

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
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FDA Advisory Committee Votes In Favor Of Moderna Flu Vaccine Benefit-Risk Profile
Moderna's investigational mRNA influenza vaccine, mRNA-1010, received unanimous support from the FDA's advisory committee based on Phase 3 clinical trial data involving over 40,000 participants. The committee determined that the vaccine's benefits outweigh its risks for adults aged 50 and older, marking a significant milestone in the regulatory review process. The FDA will now consider this recommendation as part of its evaluation, with a decision expected by August 2026.
United States Healthcare
GP
Goodwin Procter LLP
Article
Straight From The Source: DOJ, OIG, And CMS On Fraud And Abuse Enforcement In 2026 And Beyond
Three federal enforcers from CMS, HHS-OIG, and DOJ's Fraud Section outlined their coordinated approach to healthcare fraud enforcement at the AHLA Conference, revealing new strategies that prioritize prevention over recovery and leverage AI-driven detection systems. The panel discussed unprecedented interagency collaboration through a revived False Claims Act Working Group and detailed how program integrity efforts directly impact healthcare affordability, citing dramatic cost reductions in Medicare spendin
United States Healthcare
AP
Arnold & Porter
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Food and Drugs Law

Article
FDA Advisory Committee Votes In Favor Of Moderna Flu Vaccine Benefit-Risk Profile
Moderna's investigational mRNA influenza vaccine, mRNA-1010, received unanimous support from the FDA's advisory committee based on Phase 3 clinical trial data involving over 40,000 participants. The committee determined that the vaccine's benefits outweigh its risks for adults aged 50 and older, marking a significant milestone in the regulatory review process. The FDA will now consider this recommendation as part of its evaluation, with a decision expected by August 2026.
United States Healthcare
GP
Goodwin Procter LLP
Article
North Carolina Considers Overhauling Hemp Product Definition: What You Need To Know
North Carolina's House Bill 328 would fundamentally reshape the legal landscape for hemp-derived consumable products by introducing a strict 0.4 mg total THC cap per container and establishing age-21 purchase requirements. The proposed legislation would impose significant civil and criminal penalties on manufacturers, distributors, and retailers who fail to comply with the new standards taking effect in 2026.
United States Cannabis
Wa
Ward and Smith, P.A.
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Life Sciences, Biotechnology & Nanotechnology

Article
FDA Advisory Committee Votes In Favor Of Moderna Flu Vaccine Benefit-Risk Profile
Moderna's investigational mRNA influenza vaccine, mRNA-1010, received unanimous support from the FDA's advisory committee based on Phase 3 clinical trial data involving over 40,000 participants. The committee determined that the vaccine's benefits outweigh its risks for adults aged 50 and older, marking a significant milestone in the regulatory review process. The FDA will now consider this recommendation as part of its evaluation, with a decision expected by August 2026.
United States Healthcare
GP
Goodwin Procter LLP
Article
“A One-Carbon Poison Pill”: Enanta v. Pfizer And The “Typo” That Lost A Priority Date
In a high-stakes patent dispute over Pfizer's blockbuster COVID drug Paxlovid, Enanta Pharmaceuticals discovered that a single carbon atom—allegedly a typographical error in their provisional patent application—stood between them and billions in potential damages. The case explores whether courts will rescue a patentee from its own written words when the difference between "C₁" and "C₂" means the difference between patent rights and public domain, raising fundamental questions about
United States IP
YMF Law Tokyo
Article
FDA Approves Viridian’s LUMVOA For Thyroid Eye Disease
The U.S. FDA has approved LUMVOA (veligrotug-vvze) as the first treatment for thyroid eye disease with labeling that includes data from both active and chronic patient populations. This milestone marks Viridian Therapeutics' first FDA-approved medicine and commercial product, offering a new therapeutic option for patients suffering from this rare autoimmune disease characterized by inflammation and tissue remodeling around the eyes.
United States Healthcare
GP
Goodwin Procter LLP
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Healthcare

Article
White House And DOJ Gain Early Traction In Campaign Against Restrictive Hospital-Payor Contract Terms With OhioHealth Settlement
The Trump administration has intensified scrutiny of hospital-payor contracts through coordinated policy and enforcement actions, targeting provisions that allegedly limit patient choice and inflate healthcare costs. A White House economic analysis estimates that banning anti-steering, anti-tiering, and all-or-nothing contracting provisions could reduce hospital prices by up to 18% in certain markets, while the Department of Justice has secured its first settlement with OhioHealth and pursues similar litiga
United States Anti-trust
GP
Goodwin Procter LLP
Article
FDA Advisory Committee Votes In Favor Of Moderna Flu Vaccine Benefit-Risk Profile
Moderna's investigational mRNA influenza vaccine, mRNA-1010, received unanimous support from the FDA's advisory committee based on Phase 3 clinical trial data involving over 40,000 participants. The committee determined that the vaccine's benefits outweigh its risks for adults aged 50 and older, marking a significant milestone in the regulatory review process. The FDA will now consider this recommendation as part of its evaluation, with a decision expected by August 2026.
United States Healthcare
GP
Goodwin Procter LLP
Article
Mental Health Parity Compliance Continues To Challenge Employer Health Plans
The US Departments of Labor, Health and Human Services, and Treasury have released their 2025 MHPAEA Report to Congress, revealing persistent compliance failures among employer health plans regarding mental health parity requirements. The report details enforcement activities from August 2023 to July 2024, documenting hundreds of deficient comparative analyses and ongoing violations of nonquantitative treatment limitations. Despite increased regulatory scrutiny and repeated warnings, the data shows that pla
United States Employment
SR
McDermott Will & Schulte
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