Author: PharmaSignal News Desk

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.

Richard Pazdur retirement from FDA’s CDER marks a significant leadership change in 2025.

FDA animal testing guidance reduces non-human primate use, aiding U.S. drugmakers amid global competition.

Janux prostate cancer data reveals a lower response rate, impacting its clinical trial progress.

Contingent value rights are increasingly used in biotech deals, bridging price gaps amid market turbulence.