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 20, 2025

FDA Youth E-Cigarette Ad Linked to Lower Initiation

E-cigarette initiation among U.S. youth was reduced following The Real Cost Youth E-cigarette Prevention Campaign.

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 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

March 07, 2025

FDA Approves First Xolair Biosimilar

New interchangeable treatment option Omlyclo now available for patients with allergic asthma, chronic hives, nasal polyps, and food allergies; carries same boxed warning for anaphylaxis as original medication.

Conexiant

March 06, 2025

FDA Approves First Needle-Free Epinephrine for Kids

FDA approves neffy 1 mg, the first needle-free intranasal epinephrine spray for pediatric anaphylaxis.

Conexiant