Posts

FDA Delays Reviews for Eli Lilly, Sanofi, and Others in New Priority Voucher Program Due to Safety and Efficacy Concerns

Are the Good Times in Biotech Back? – Insights from Post-Hoc Live’s 2025 Industry Sentiment

US Government Shutdown Threatens to Stress an Already Depleted FDA

FDA Delays Draw Contrasting Responses: Neurizon Cites Agency Strain, Omeros Takes Softer Tone

Novavax Approval Process Raises Concerns Among Former Regulators About FDA Integrity

FDA Delays Continue as Regulator Misses Review Date for GSKs Nucala

Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs