Author: PharmaSignal News Desk

ACIP vaccine schedule is under review by a panel, following changes to the hepatitis B vaccine endorsement.

Hemophilia gene therapy faces market challenges despite innovation, with BioMarin, CSL, and Pfizer navigating barriers.

Praxis shares rise 40% following positive updates on two drugs, while Bristol Myers’ Breyanzi gains approval for a fifth cancer indication.

CDC panel delays vote on hepatitis B vaccine for newborns, impacting public health.

• CDC panel delays decision on hepatitis B vaccine.
• Vote affects millions of newborns annually.
• Public health implications are significant.

SciNeuro Pharmaceuticals funding of $53M aims to advance neurodegeneration drug development, supported by Arch Venture Partners.

FDA chiefs critique plans to toughen vaccine standards, impacting COVID-19 protocols.

FDA CDER leadership change sees Tracey Beth Høeg appointed as director, marking the fifth leadership shift in 2025.

UniQure Huntington’s gene therapy faces challenges as FDA deems current data insufficient for approval, affecting market outlook.

Capricor Duchenne cell therapy shows positive results, potentially reversing FDA rejection and quadrupling shares.

Pharvaris Phase 3 Success marks a significant milestone in hereditary angioedema treatment, potentially impacting over 8,000 patients in Europe.