Dulaglutide Cardiovascular Outcomes: REWIND Trial 9901, HR 0.88
REWIND trial data: 9,901 patients, 12% MACE risk reduction (HR 0.88) with dulaglutide, leading to Trulicity's 2020 FDA cardiovascular indication.
Dulaglutide Trulicity: Regulatory History
8 source-based articles maintained by the HealthRX.com Editorial Team.
8articles
4topic areas covered
Jul 10, 2025latest review
Dulaglutide Trulicity: Regulatory History library
Showing 8 of 8 clinical reviews.
Trulicity (Dulaglutide) FAERS Safety Signals: What Post-Market Surveillance Shows
A detailed review of dulaglutide (Trulicity) safety signals reported through the FDA Adverse Event Reporting System (FAERS), including gastrointestinal events, pancreatitis, thyroid concerns, and cardiovascular outcomes from the REWIND trial.
Trulicity (Dulaglutide) FDA Approval History: Timeline, Label Changes, and Safety Updates
Complete FDA approval history of Trulicity (dulaglutide), including original 2014 approval, CVOT-driven label expansions, boxed warning details, and post-market safety signals from FAERS and Sentinel.
Trulicity (Dulaglutide) Global Regulatory Status
A complete regulatory overview of Trulicity (dulaglutide), covering FDA approval, EMA authorization, label expansions, REWIND cardiovascular data, post-market safety signals, and current global market access.
Trulicity (Dulaglutide) Legal and Patent Challenges: FDA History, Litigation, and What Comes Next
A clinical review of Trulicity's regulatory timeline, patent disputes, Paragraph IV litigation, and post-market safety actions that shape dulaglutide access in 2026.
Trulicity Compounding Legal Status: What Patients and Prescribers Need to Know
A complete regulatory guide to Trulicity (dulaglutide) compounding legal status, FDA approval history, label requirements, and post-market safety data. prepared by the HealthRX.com Editorial Team.
Trulicity EMA vs FDA Approach: Regulatory Differences Explained
A detailed comparison of how the FDA and EMA evaluated, approved, and monitor dulaglutide (Trulicity), including label differences, post-market obligations, and what each framework means for patients and prescribers.
Trulicity Label Updates 2020 to 2026: A Complete FDA Regulatory Timeline for Dulaglutide
Trulicity side effects and safety: a Boxed Warning for thyroid C-cell tumors, plus pancreatitis, anaphylaxis, kidney injury, ileus and nausea warnings.