Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
US FDA’s June User Fee Calendar Starts Out Steady, But A Crescendo Of Decisions Will Start Mid-Month
Two gene therapies and two novel inhibitors of JAK kinases are among the upcoming goal dates from the Pink Sheet’s US FDA Performance Tracker.
Broad Heart Failure Label Ushers Lexicon’s Inpefa Into SGLT2 Inhibitor Market
Sotagliflozin’s cardiovascular outcomes trials support the most expansive heart failure risk reduction claim approved by the US FDA in the class, a turnaround from the drug’s setbacks in type 1 diabetes.
Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else
Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.
US FDA Complete Response Letter Rates Vary With Sponsor Size
Pink Sheet infographic illustrates benefits of big pharma’s resources and experience.
Everybody Stumbles: US FDA Complete Response Letters To Big Pharma
Explore the 20 CRLs issued to biggest pharma firms since the start of 2021 with Pink Sheet infographic describing US FDA’s concerns and current status.
Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters
Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.