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

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

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 25, 2025

FDA Approves Penpulimab-kcqx for NPC

The FDA approved penpulimab-kcqx for first line and previously treated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.

Conexiant

April 04, 2025

First IgG4-RD Treatment Approved

A humanized monoclonal antibody that targets CD19+ B cells is first FDA-approved treatment for immunoglobulin G4–related disease, reducing flare risk and glucocorticoid use in clinical trials.

Conexiant

April 02, 2025

FDA Misses Novavax Decision Date

FDA misses April 1 deadline for deciding on Novavax's COVID-19 vaccine.

Reuters

April 02, 2025

FDA Approves Automated Latent TB Test

Revvity’s Auto-Pure 2400 platform for use with the T-SPOT.TB test to automate latent tuberculosis diagnostics was approved by the FDA.

Conexiant

April 16, 2025

RSV Vaccine Access Under CDC Review

“An estimated 15,000–20,000 annual RSV-associated hospitalizations occur in adults aged 50–59”—prompting CDC advisers to revisit age-based vaccine recommendations.

Reuters