Bridget Silverman
Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
Vaccine Decisions: US FDA And CDC Weigh New Vaccines For Diseases From Dengue To RSV
Pink Sheet infographic show US regulatory forecast for the many new vaccines facing the twin tests of FDA approval and CDC recommendation, which are both needed to effectively access the US commercial marketplace.
Keeping Track: Pharming’s Joenja, Cidara’s Rezzayo And Incyte’s Zynyz Headline US FDA Approval Bonanza
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Lessons Still To Learn: Cytokinetics’ Omecamtiv Is Over In The US, But FDA Debriefs Could Inform European Strategy
Cytokinetics will not conduct the new trial in heart failure with reduced ejection fraction (HFrEF) required by the FDA’s complete response letter for omecamtiv mecarbil.
Keeping Track: Opdivo, Keytruda Continue Adjuvant Push As Cancer Dominates Recent Applications
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Reata’s Skyclarys Approval Aided By Natural History And Delayed-Start Analyses
The first treatment for the rare neurodegenerative disorder Friedreich’s ataxia relied on a single placebo-controlled efficacy trial.