United States: Life Sciences, Biotechnology & Nanotechnology

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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.

Health Headlines: January 2026

On January 22, 2026, the House of Representatives passed HR 7148, an appropriations package that would finance the U.S. Department of Health and Human Services and other agencies.

United States Healthcare

GP

Goodwin Procter LLP

Virtual And Digital Health Digest – December 2025

Welcome to the latest installment of Arnold & Porter's Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2025...

United States Healthcare

AP

Arnold & Porter

New Draft Guidance Addresses FDA's Records Access Authority For Cosmetics Under MoCRA

On January 21, the US Food and Drug Administration (FDA) issued a draft guidance clarifying the agency's authority to access and copy records related to cosmetic products under the Modernization...

United States Healthcare

AF

ArentFox Schiff

Virtual And Digital Health Digest

This digest covers key virtual and digital health regulatory and public policy developments during December 2025 and early January 2026 from the United States, United Kingdom, and European Union.

Worldwide Healthcare

AP

Arnold & Porter

Outbreak Of New World Screwworm Highlights Importance Of Insect Sterilization Technique Technology And Regulation

United States Healthcare

BD

Beveridge & Diamond

SEC Enforcement Action Targets Insider Trading In The Pharmaceutical Industry

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

AI, Patents, And Precision Medicine: Highlights From Foley & Lardner's 2026 Health Care & Life Sciences Trends Report

United States Technology

FL

Foley & Lardner

Self‑Collection Kits In The Crosshairs

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

Virtual And Digital Health Digest - January 2026

Worldwide Healthcare

AP

Arnold & Porter

Top 10 Issues In Cross-Border Life Sciences Transactions

Worldwide Healthcare

GP

Goodwin Procter LLP

Holland & Knight Health Dose: January 27, 2026

United States Healthcare

HK

Holland & Knight

Digital Health Policy: FDA Relaxes Restrictions Over Wearables And AI Decision Making Tools In Two New 2026 Guidances

United States Healthcare

FL

Foley & Lardner

AbbVie And Novartis Announce Billion Dollar Licensing Deals For Oncology And Alzheimer's Treatments

United States Healthcare

GP

Goodwin Procter LLP

Health Care Enforcement Trends & 2026 Outlook

United States Healthcare

M

Mintz

Food Venture Financing News – Weekly Issue No. 265

United States Healthcare

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Davis Wright Tremaine

Federal Circuit: Priority Document That 'Broadly Outlines' Possible Structures Fails To Provide Adequate Written Description Support For Subgenus Of Linkers In Antibody-Drug Conjugate

United States IP

AG

Akin Gump Strauss Hauer & Feld LLP

Ohio's New E-Verify Workforce Integrity Act: What Construction Employers Need To Know

United States Immigration

Gs

Green and Spiegel

Simpson Thacher Sustainability And ESG: Regulatory Update – January 2026

Worldwide Environment

ST

Simpson Thacher & Bartlett

401(k) And IRA Contribution Limits For 2026: Retirement Savings, Adjustments For Inflation, And SECURE 2.0 Changes American Taxpayers Must Know About

United States Tax

RS

Rotfleisch & Samulovitch P.C.

NMED Posts Revised Proposed PFAS Reporting, Labeling, And Prohibition Rule

On January 16, 2026, the New Mexico Environment Department (NMED) posted docket materials related to the New Mexico Environmental Improvement Board's (NMEIB) February 23, 2026, rulemaking hearing on per- and polyfluoroalkyl substances (PFAS) in consumer products.

United States Environment

BC

Bergeson & Campbell

Hybrid Financing In Life Sciences: Unlocking Growth Amid Market Challenges

Life sciences companies and investors continue to navigate a complex and challenging investment landscape – marked by high interest rates, a volatile regulatory environment, tight venture capital (VC)...

United States Healthcare

SR

McDermott Will & Schulte

Where Healthcare Exits Are Heading In 2026

As we look to 2026, exits aren't just about timing. Dealmakers are utilizing process, planning, and creativity to find new paths to liquidity.

United States Healthcare

SR

McDermott Will & Schulte

Absent Congressional Action, Most Laboratories Required To Submit Outdated Data To CMS Beginning February 1, 2026

After years of delays, the Centers for Medicare & Medicaid Services (CMS) is preparing to update the Clinical Laboratory Fee Schedule's (CLFS) reimbursement rates for clinical diagnostic laboratory tests (CDLTs)...

United States Healthcare

BB

Bass, Berry & Sims

DOJ's FY 2025 FCA Numbers Send A Clear Message: Enforcement Risk Is Rising

United States Healthcare

AP

Arnold & Porter

2026 Health Care Reimbursement Newsletter

United States Healthcare

PL

Polsinelli LLP

Fewer Cases, Higher Stakes: SEC Enforcement Trends For Pharmaceutical, Life Sciences, And Healthcare Companies Heading Into 2026

United States Healthcare

SR

McDermott Will & Schulte

FDA In Flux — January 2026 Newsletter

United States Healthcare

M

Mintz

A Smarter Approach To Evaluating AI Life Sciences Investments

United States Technology

SR

McDermott Will & Schulte

Immigrant Access To Health Centers: Confronting Unknowns In The Administration's Revised Interpretation Of PRWORA

United States Healthcare

FL

Foley & Lardner

Q&A With Former US Attorney Erek L. Barron On Enforcement Trends, Qui Tam Risks, And Strategic Opportunities — EnforceMintz

United States Criminal

M

Mintz

To Monetize Or Not To Monetize? The Question Late-Stage Life Sciences Companies Should Be Asking

United States Healthcare

GP

Goodwin Procter LLP

Atlantic Biologicals Opioid DPA: DOJ Continues Ramp Up Of Criminal Corporate Healthcare Enforcement

United States Healthcare

CM

Crowell & Moring LLP

Supreme Court Grants Cert. Petition In Hikma / Amarin Skinny Labeling Case

United States IP

PL

Polsinelli LLP

Q&A With Former US Attorney Erek L. Barron On Enforcement Trends, Qui Tam Risks, And Strategic Opportunities — EnforceMintz

The Department of Justice (DOJ) is pairing aggressive health care fraud enforcement with a mandate for restraint.

United States Criminal

M

Mintz

To Monetize Or Not To Monetize? The Question Late-Stage Life Sciences Companies Should Be Asking

Over the last few years, royalty monetization deals have solidified their status as important financing alternatives for late-stage life sciences companies to consider in their fundraising initiatives.

United States Healthcare

GP

Goodwin Procter LLP

Atlantic Biologicals Opioid DPA: DOJ Continues Ramp Up Of Criminal Corporate Healthcare Enforcement

On January 13, 2026, Miami-based pharmaceutical wholesaler Atlantic Biologicals Corporation entered into a two-year DPA, admitting to conspiracy to distribute and dispense controlled substances...

United States Healthcare

CM

Crowell & Moring LLP

Supreme Court Grants Cert. Petition In Hikma / Amarin Skinny Labeling Case

In what is certainly one of the hottest cases to watch relating to skinny labeling and induced infringement for the pharmaceutical industry, the Supreme Court granted Hikma's cert.

United States IP

PL

Polsinelli LLP

ASP Reporting Gets A Major Update In The CY 2026 PFS

United States Healthcare

SR

McDermott Will & Schulte

FDA's Guidance On The Use Of Real-World Evidence For Medical Devices

Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.

United States Healthcare

CO

Cozen O'Connor

BIOSECURE Act: What You Need To Know

The National Defense Authorization Act for Fiscal Year 2026, signed into law on 18 December 2025, includes the BIOSECURE Act (the Act), which establishes a new framework governing the use of certain biotechnology equipment and services ...

United States Healthcare

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K&L Gates LLP

Personalizing Cancer Therapy For Complex Molecular Blueprints: Insights From The I-PREDICT Trial

One of the persistent challenges in precision oncology is the fact that most advanced cancers are complex and highly individualized. A recent study published by Jason K. Sicklick, MD and colleagues (J. Clinical Oncology) tackles and provides a possible solution to this problem.

United States Healthcare

FL

Foley & Lardner

GLP-1 Coverage Expansion Under Medicare: What Digital Health Companies Need To Know

The Trump administration has announced a pricing initiative designed to reduce the cost of glucagon-like peptide-1 (GLP-1) drug products for certain Medicare enrollees.

United States Healthcare

SR

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | November 2025 Recap

United States Healthcare

SR

McDermott Will & Schulte

ACI's 13th Annual Legal, Regulatory & Compliance Forum On Cosmetics & Personal Care Products

United States Healthcare

HP

Hyman, Phelps, & McNamara

Episode 367 - In-Conversation: Jamie Metzl On The Superconvergence Of The AI, Biotech & Genetics Revolutions (Podcast)

United States Healthcare

CO

Cozen O'Connor

FDA Updates Its "General Wellness" Device Framework—What Companies Need To Know

United States Healthcare

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Loeb & Loeb LLP

"Deregulation" On The Menu: Big Changes For Wellness And CDS Technologies

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Jones Walker On Digital Healthcare Trends And Developments

United States Healthcare

JW

Jones Walker

Federal Circuit Strikes Life Sciences Patent Over Insufficient Disclosure Of Particular Species

United States IP

PL

Polsinelli LLP

浅析美国专利法第112条书面描述要求及生物医药领域应对策略

United States IP

CP

CCPIT Patent & Trademark Law Office

ACI's 3rd Annual Life Sciences AI Summit

United States Healthcare

HP

Hyman, Phelps, & McNamara

The New Playbook For Competitive Life Sciences M&A — How Buyers Can Differentiate Beyond Price Through Structure And Strategy

United States Healthcare

GP

Goodwin Procter LLP

Year In Review: Big Deals Of 2025

United States Healthcare

GP

Goodwin Procter LLP

Life Sciences Capital Markets: Preparing For Your 2026 IPO

United States Healthcare

GP

Goodwin Procter LLP

FDA Is Open To The Idea Of Possible Regulatory Flexibility For Cell And Gene Therapies On A Case-by-Case Basis…Where Appropriate

United States Healthcare

HP

Hyman, Phelps, & McNamara

Turning Insight Into Action: A Life Sciences Playbook For 2026

United States Commercial

PL

Polsinelli LLP

Telehealth Update: Telehealth Flexibilities, Convictions And Indictment, And 2026 Outlook

United States Healthcare

M

Mintz

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Highlighted Content

Plausibility At The EPO – An Update On G2/21

United States Healthcare

D

Dehns

Infringement Of Repurposed Drug Patents And Skinny Labelling – Where Does The Balance Lie In The United States Today?

United States Healthcare

D

Dehns

Infringement Of Repurposed Drug Patents And Skinny Labelling – Where Does The Balance Lie In Europe Today?

United States Healthcare

D

Dehns

How Good Does A Copy Need To Be?

United States Healthcare

D

Dehns

Supplementary Protection Certificates – European Patent Term Extensions

United States Healthcare

D

Dehns

How Much Experimental Data Is Needed For Patent Applications In Europe?

United States Healthcare

D

Dehns

Implications Of The Genetic Technology (Precision Breeding) Bill On The Life Science IP Sector

United States Healthcare

D

Dehns

Protection For Plant Varieties In Europe And The UK Post-Brexit

United States Healthcare

D

Dehns

Best Practice For Invention Harvesting

United States Healthcare

D

Dehns

ADR And Diversity In The Life Sciences Sector

United States Commercial

J

JAMS

Latest Videos

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Episode 37: Chanda Center For Health: Reimagining Access To And Delivery Of Long-term Disability Care (Podcast)

FL

Foley & Lardner

Critical Medical Device Series: Part X Balancing Risk And Innovation: Fraud And Abuse Trends For MedTech (Video)

AP

Arnold & Porter

Non-binding Guidance: The Administration's Focus On Direct-to-Consumer Prescription Drug Advertising (Podcast)

RG

Ropes & Gray LLP

Inside MedTech Translation Challenges: Ensuring Multilingual Regulatory Compliance

Moringside

Leveraging Technology To Create A Next Generation Academic Medical Center In Austin (Video)

AM

Alvarez & Marsal

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