Pink Sheet Podcast: Zolgensma Saga Continues, ICER Reviews DMD Drugs, FDA Issues Another LPAD Approval
Executive Summary
Pink Sheet reporters review Novartis' latest response to Zolgensma data manipulation, discuss ICER reviews of Sarepta's Duchenne muscular dystrophy treatments, and recap the FDA's latest antibiotic approval.
You may also be interested in...
US FDA Hopes Food, Inspection Office Reorg Bolsters Innovative Clinical Trial Adoption
Ensuring inspectors understand the innovative trial designs in use before an inspection will be important to increasing industry confidence in their use, CDER Director Patrizia Cavazzoni said.
US FDA's CDER Creates Quantitative Medicine Center Of Excellence; Job Includes AI Oversight
The group will coordinate quantitative medicine issues throughout the FDA's Center for Drug Evaluation and Research to help streamline drug development.
Pink Sheet Podcast: Mifepristone And Misinformation At SCOTUS, Understanding US FDA’s ODAC
Pink Sheet reporters and editor discuss the upcoming US Supreme Court arguments on mifepristone access, the SCOTUS reaction to the fight against misinformation, and the FDA’s Oncologic Drugs Advisory Committee going against three negative product reviews.