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Jenna Raspanti

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JRaspanti@gibsondunn.com

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2026 Life Sciences Industry Outlook: Regulatory Environment

January 16, 2026 | Posted by Katlin McKelvie; John D.W. Partridge; Lindsay Paulin; Michael Perry; Jonathan M. Phillips; Adam M. Smith; Carlo Felizardo; Samantha Sewall; Hui Fang; Jenna Raspanti; Lindsay Bernsen Wardlaw; Topic(s): Antitrust; False Claims Act; FDA; FDA Guidance; Government Regulation; International Trade; Trends and Insights

Welcome to Part 5 of our 2026 Life Sciences Industry Outlook series. Today, we are wrapping up the week with a review of the regulatory environment for life sciences companies in 2025 and our expectations for what 2026 could bring.

In 2025, life sciences companies faced a fast-moving regulatory environment shaped by the Trump administration’s priorities, including deregulation, the use of policy levers to encourage domestic manufacturing and development, and efforts to reduce healthcare costs for American consumers. We expect this unpredictable atmosphere to continue into 2026. In particular, we anticipate regulatory and enforcement developments in FDA regulation, drug pricing and reimbursement, government contracts, tariffs, and antitrust oversight, although specific outcomes and impacts remain difficult to predict.

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Read Our Life Sciences 2026 Outlook here.

Topics

Antitrust

Capital Markets

Clinical Trials

CVR Spinoff

CVRs

Delaware Law

ECVC

False Claims Act

FDA

FDA Guidance

Government Regulation

International Trade

IPOs

License Agreements

M&A

Manufacturing

Reverse Mergers

Royalty Finance

SEC Disclosure

SEC Updates

Securities Litigation

Shareholder Activism

Tax

Trends and Insights

Editors

Rachel E. Baron

Branden C. Berns

Aaron K. Briggs

Jina L. Choi

Matt Donnelly

Pamela Lawrence Endreny

Gustav W. Eyler

Hui Fang

Carlo Felizardo

Mark Goldman

Bree Gong

Charlotte Jacobsen

Candice D. Johnson

Jin Hee Kim

Wynne Leahy

Nicholas G. Linke

Jeff Lombard

Jane M. Love, Ph.D.

Mary Beth Maloney

Katlin McKelvie

Ryan A. Murr

Melanie E. Neary

John D.W. Partridge

Lindsay Paulin

Michael Perry

Jonathan M. Phillips

Jenna Raspanti

Ryan Rott

Lindsey D. Schmidt

Samantha Sewall

Sam Shapiro

Evan Shepherd

Eric B. Sloan

Adam M. Smith

Bradley P. Smith

Karen A. Spindler

Eric J. Stock

Ayushi Sutaria

Xuan Hong Tran

Terrell Ussing

Jessica Valenzuela

Lindsay Bernsen Wardlaw

Stephen Weissman

Kamia Williams

Maggie Zhang

Useful Links

  • Gibson Dunn Website
  • Gibson Dunn Life Sciences Landing page
  • Securities Regulation and Corporate Governance Monitor
  • NVCA Model Legal Documents
  • Royalty Finance Tracker
  • Royalty Report: Royalty Finance Transactions in the Life Sciences 2020-2024
  • IPO Resource Center
  • IP Disputes and Litigation

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