Bridget Silverman
Senior Editor
Latest From Bridget Silverman
Keeping Track: US FDA Clears Another CAR-T And Another Novel ADHD Drug; Submissions Blossom
The latest news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Keeping Track: Zegalogue Joins Hypoglycemia Space; Keytruda Earns First-Line Esophageal Cancer Claim
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
April User Fee Goal Calendar: Forecast Uncertain For Atopic Dermatitis Candidates, Nuplazid; Eohilia Could Be First For Orphan Use
While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.
Keeping Track: US FDA Approves J&J’s Novel MS Drug Ponvory, Breakthrough Pericarditis Claim For Kiniksa’s Arcalyst
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Keeping Track: Recent NDA Submissions Range From Acute Agitation To Von Hippel-Lindau Disease
News and highlights of applications submitted for US FDA approval, from the Pink Sheet’s FDA Performance Tracker
Pandemic Perspectives: US FDA ACTT’s On Its Faith In Randomized Trials With Veklury Approval Despite WHO Study
US FDA has not deviated from its bedrock trust in the value of ‘statistically reliable’ endpoints amidst the COVID-19 pandemic, the Pink Sheet’s Drug Review Profile of Gilead’s Veklury shows.