June 06, 2025

FDA Monthly Round-up: Key May Updates

May’s FDA approvals include the first at-home HPV test, a blood-based Alzheimer’s diagnostic, biosimilars, AI-enabled imaging tools, and novel therapies across cardiology, pulmonology, neurology, gastroenterology, and more.

Conexiant

June 03, 2025

FDA Grants Breakthrough Status to Shield Test

The methylation-based blood assay is designed for screening multiple cancer types.

Conexiant

May 30, 2025

Paging Dr. Canada: U.S. Exodus

Amid Trump’s return, more American doctors are fleeing to Canada, citing political fear, violence, and a collapsing health care climate.

KFF Health News

May 28, 2025

Kennedy Proposes NIH Publishing Ban

"We're probably going to stop publishing in The Lancet, New England Journal of Medicine, JAMA, and those other journals because they're all corrupt."

Conexiant

May 28, 2025

FDA Clears AI Upgrade for Portable MRI

Optive AI software enhances image quality for the Swoop system.

Conexiant

May 20, 2025

Clinical Trials Missing in Half of AI Tools

Researchers analyzed FDA-approved AI-enabled medical devices and reported that clinical performance and subgroup data were frequently missing.

Conexiant

May 16, 2025

FDA Clears First Blood Test for Alzheimer’s

The FDA has cleared the first blood-based test to aid in diagnosing Alzheimer’s disease, offering a less invasive alternative to positron emission tomography scans and cerebrospinal fluid testing for cognitively impaired patients.

Conexiant

May 16, 2025

FDA Approves PD-1–Targeted Monoclonal Antibody for SCAC

The FDA has approved Zynyz (retifanlimab-dlwr) as the first programmed death receptor-1 inhibitor for first-line treatment of advanced squamous cell carcinoma of the anal canal.

Conexiant

April 01, 2025

FDA Approves Freeze-Dried Jynneos Vaccine

Bavarian Nordic’s freeze-dried Jynneos vaccine offers logistical advantages over the liquid-frozen version, supporting long-term U.S. stockpiling and public health preparedness.

Conexiant