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 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

March 31, 2025

Tariff Threat: Drugs Could Cost U.S. $750M More

New research reveals 25% tariffs on Canadian pharmaceuticals would impact critical medications, strain supply chains, and potentially increase costs—with 28 drugs having no alternative suppliers.

Conexiant

March 25, 2025

Most Pediatric Valve Implants Used Off-Label

Fewer than 10% of cardiac valve devices implanted in U.S. pediatric patients were FDA approved for children.

Conexiant

March 14, 2025

FDA Recommends Influenza Vaccine Strains for 2025 to 2026

The FDA has selected influenza vaccine strains for the 2025 to 2026 U.S. flu season, maintaining consistency with prior formulations while incorporating updated epidemiologic and antigenic data to optimize protection.

Conexiant

March 13, 2025

FDA Chief Counsel Resigns Two Days In

U.S. FDA's chief counsel resigns amidst controversy surrounding her appointment and connections to mifepristone during the Biden administration.

Reuters

March 11, 2025

FDA's New Pulse Oximeter Guidance: Stricter Standards, Ongoing Challenges

The FDA's 2025 pulse oximetry guidance introduces stricter accuracy standards, larger study cohorts, and objective skin pigmentation assessment to address measurement bias in darker-skinned patients.

Conexiant

March 10, 2025

AI Methods Strengthen Real-World Data Reliability

Researchers assessed the impact of AI-driven methods on real-world data reliability, showing improvements in accuracy, completeness, and traceability

Conexiant