Bridget Silverman
Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
Collaboration Makes The (Real) World Go Round: Global Efforts Strive To Anchor RWE With Real-World Data Standards And Practices
Can the decentralized global healthcare ecosystem to turn real-world evidence from a buzzword to a useful approach to fit-for-purpose evidence generation?
Piloting Real-World Evidence: US FDA RWE Demonstration Projects
Agency offers three informal ‘buckets’ organized around data, study design and tools.
Keeping Track: Early Thanks Given By ImmunoGen, Provention Bio; More PD-1/L1 Combo Approvals
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Keeping Track: Gilead Gets CRL For Bulevirtide, CytoDyn Withdraws Leronlimab; Eye and CNS Drug Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Can Viatris’ Revived Revatio Bid In Pediatric PAH Overcome Past Obstacles To US FDA Approval?
Behind FDA’s decision to call, and then to call off, an advisory committee for pediatric use of Viatris’ Revatio (sildenafil) in pulmonary arterial hypertension lies a debate going back more than a decade, review documents show.
November Gloom? US FDA’s Goal Dates Include Hard Calls On Ferring Rebyota, Y-mAbs’ Omblastys
November should see FDA action on what could be the first standardized fecal microbiota transplant product, rare cancer therapies from Y-mAbs and Spectrum, uniQure/CSL’s hemophilia B gene therapy and Provention Bio’s biologic to delay type 1 diabetes.