FDA Approves Dupixent as First Chronic Spontaneous Urticaria Therapy in Over a Decade
The U.S. Food and Drug Administration (FDA) has approved Dupixent as the first new targeted therapy in over ten years for chronic spontaneous urticaria in patients aged 12 and older who remain symptomatic despite antihistamine treatment, according to a report by Becker’s Hospital Review.

The approval is based on data from three phase 3 trial results which showed that Dupixent, when added to standard antihistamine treatment, reduced itch severity and hives more than antihistamines alone after 24 weeks, according to an April 18 Sanofi press release. 

Becker’s Hospital Review reports CSU as a chronic skin condition that causes unpredictable hives and itching. In the U.S., more than 300,000 individuals aged 12 and older live with CSU and do not respond to antihistamines. The condition is linked to Type 2 inflammation, which Dupixent helps target by blocking certain immune signaling pathways. 

The injection is already approved for CSU in several other countries, including Japan and Brazil, and regulatory reviews for other countries are ongoing, according to the report. 

CISA Releases Guidance on Risks Associated with Potential Legacy Oracle Cloud Compromise
The Cybersecurity and Infrastructure Security Agency (CISA) recently published guidance on mitigating risks associated with a potential unauthorized access incident involving a legacy Oracle cloud environment, according to the U.S. Dept. of Health and Human Services (HHS). 

While the scope and impact of the incident remain unconfirmed, CISA warns that the reported activity could pose significant risks to both organizations and individuals—particularly where credentials such as usernames, passwords, authentication tokens, and encryption keys may have been exposed. The agency highlights that embedded credentials—those hardcoded into scripts, infrastructure templates, or automation tools—are especially dangerous, as they are often difficult to detect and can provide persistent unauthorized access if compromised.

Threat actors frequently exploit stolen credentials to escalate privileges, move laterally within networks, access cloud and identity management systems, launch phishing or business email compromise campaigns, and sell access on criminal marketplaces. 

In response, CISA recommends several mitigation steps. Organizations should reset passwords for any known affected users, especially where local credentials are not managed via enterprise identity systems. They should also review code and configurations for embedded credentials and replace them with centralized secret management solutions. 

Additionally, CISA urges organizations to monitor authentication logs for unusual activity, enforce phishing-resistant multi-factor authentication (MFA), and ensure that all privileged and service accounts are secured. 

For more details, review the CISA guidance.

REGISTER: Mastering De-Escalation in Health Care Webinar
A free American Society for Health Care Risk Management webinar, “Mastering De-Escalation in Healthcare: From Recognition to Resolution,” will provide healthcare professionals with the knowledge and tools to handle challenging interactions. 

Attendees will gain a deeper understanding of the legal obligations surrounding workplace safety in healthcare settings and learn practical approaches to prevent and respond to incidents of workplace violence. 

Click here to register for the April 22 webinar. 

Improving Diagnostic Safety Initiative
Diagnostic safety events occur across all healthcare settings contributing to preventable harm in one out of 20 outpatient visits and 250,000 inpatient stays each year.

IHA and MAPS PSO have partnered with RAND, the Institute for Healthcare Improvement, Convergence Health and the Agency for Healthcare Research and Quality (AHRQ) to recruit healthcare organizations to participate in AHRQ's Implementing Diagnostic Excellence Across Systems (IDEAS) program.

Organizations participating in the IDEAS project will pilot and integrate AHRQ tools such as Calibrate Dx, Measure Dx and the Toolkit for Engaging Patients in Diagnostic Safety. By taking part, organizations will:

• Gain access to support and training from content subject matter experts;
• Qualify to receive continuing education (CE) credits;
• Fulfill new CMS Patient Safety Structural Measure requirements;
• Be eligible for Merit-Based Incentive Payment System (MIPS) credits
• Receive a $1,500 stipend per participating site.

Review our slide presentation from April 2, and listen to the recording (password: IDEASInitiative2025) for more information. After reviewing, please take a moment to fill out a quick 3-question form to express your interest. 

We encourage you to get involved and take advantage of utilizing resources and tools that assist organizations in learning from diagnostic safety events. Join this national effort and take part in improving diagnostic safety across your health system.

Contact QualityPatientSafety@team-iha.org with any questions.