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

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 29, 2025

HHS Questions Pediatric Gender Treatment Evidence

HHS review finds weak evidence for puberty blockers, hormones in minors with gender dysphoria, urges protocol updates.

Conexiant

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 27, 2025

Minimally Invasive Option for Severe Mitral Annular Calcification

The FDA has approved Abbott’s Tendyne system, the first transcatheter mitral valve replacement for patients with severe mitral annular calcification who are ineligible for open-heart surgery.

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

May 05, 2025

FDA Monthly Round-up: Key April Updates

April’s FDA approvals feature first-in-class therapies, targeted biologics, expanded indications, and innovative delivery systems across allergy, endocrinology, rheumatology, oncology, infectious diseases, and more.

Conexiant

May 06, 2025

FDA Approves TAVR Platform for Asymptomatic AS

The FDA has approved the SAPIEN 3 TAVR platform for patients with asymptomatic severe aortic stenosis based on data from the EARLY TAVR trial.

Conexiant