Bridget Silverman
Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
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.
After ACIP Gambit, Pfizer, GSK Take RSV Vaccines To US FDA Adcomm
The Vaccines and Related Biological Products Advisory Committee is scheduled to consider the RSV vaccine candidates on 28 February and 1 March.
Nasal Naloxone On Brink Of OTC Among Additional Opioid Overdose Options On US FDA's Plate
Upcoming goal dates for Emergent’s Narcan and Harm Reduction Therapeutics’ RiVive will test the US FDA’s efforts to nurture the over-the-counter naloxone switch, followed by decisions on higher strength nasal opioid antagonist products from Opiant and Orexo to address fentanyl and other synthetic opioids.