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 23, 2025

More Data, Please: FDA to Novavax

Novavax reveals FDA's request for more clinical data if COVID-19 vaccine is approved and expresses confidence in approval based on discussions.

Reuters

April 18, 2025

Intranasal Diazepam Gains Expanded Approval for Pediatric Patients

“Approval of an immediate-use intranasal diazepam treatment that can be given at any time—even while a child is actively seizing—in this young age group is an important advance for the epilepsy community.”

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

April 15, 2025

ACIP to Weigh COVID, RSV, Measles Shots

The CDC's expert panel convenes to discuss next-gen COVID-19 shots and vaccination guidelines for various diseases amid a US measles outbreak.

Reuters

April 10, 2025

FDA Clears Stapler for Single-Port Surgery

The FDA has cleared Intuitive’s SP SureForm 45 stapler, the first stapler designed for single-port robotic surgery using the da Vinci SP system.

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