delays
Are the Good Times in Biotech Back? – Insights from Post-Hoc Live’s 2025 Industry Sentiment
biotech sentiment; Post-Hoc Live; 2025 industry outlook; biotech M&A; FDA delays; executive survey; public biotech companies; JP Morgan effect; biotech funding
US Government Shutdown Threatens to Stress an Already Depleted FDA
Government shutdown; FDA operations; drug approval delays; FDA staff cuts; user fees; public health; federal funding; regulatory delays
FDA Delays Draw Contrasting Responses: Neurizon Cites Agency Strain, Omeros Takes Softer Tone
FDA delays; Neurizon Therapeutics; Omeros Corporation; regulatory review; NUZ-001; narsoplimab; ALS; transplant drugs; agency staffing shortages; clinical hold
Novavax Approval Process Raises Concerns Among Former Regulators About FDA Integrity
Novavax; FDA approval; COVID-19 vaccine; regulatory process; integrity concerns; delays; political interference
FDA Delays Continue as Regulator Misses Review Date for GSKs Nucala
United States Food and Drug Administration, Nucala, Chronic Obstructive Airway Disease, GSK ‘s, Target, delays, PDUFA
Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs
FDA layoffs , Drug review delays , User Fee Programs , PDUFA , Regulatory challenges , FDA budget cuts , Medical device approval , Biopharma regulatory issues , RFK Jr. HHS layoffs , FDA operational disruptions