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

Gene Therapy Trial Halted After Fatal Turn

A gene therapy trial for Danon disease is on FDA hold after a patient death tied to a new immune-suppressing agent

Reuters

May 20, 2025

FDA Releases Guidance to Accelerate Generic Drugs

The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."

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 19, 2025

Bacteria Eat, Exploit Plastic: Study 

A hospital-derived strain of Pseudomonas aeruginosa was found to degrade medical plastic, use it as food, and form stronger biofilms, revealing new risks for device-related infections.

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

May 15, 2025

FDA Approves Therapy for NSCLC With High c-Met Protein Overexpression

The FDA granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis), a c-Met–directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, nonsquamous...

The ASCO Post

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

April 03, 2025

New Option for IgA Nephropathy Management

The FDA has granted accelerated approval to Vanrafia (atrasentan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy who are at risk of rapid disease progression.

Conexiant