Bridget Silverman
Senior Editor

Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Bridget Silverman
Novartis And The Medicines Company: Five Things To Worry About
The $9.7bn acquisition hinges on the small interfering RNA inclisiran, but an ongoing cardiovascular outcomes trial, manufacturing hurdles, and reimbursement challenges provide subjects for concern.
Keeping Track, Oncology Edition: Biologic Breakthroughs And BLAs
The latest oncology development news and highlights from our US FDA Performance Tracker.
Real-World Database Studies: Prepare For A Long Journey, IQVIA Advises
Rigorous planning and a multidisciplinary team including database experts and healthcare specialists with local knowledge are vital to effective real-world evidence, white paper shows.
Keeping Track: Submissions From Alkermes, Samsung Bioepis; BTDs for Orphazyme and Kiniksa
The latest submission and expedited review program news and highlights from our US FDA Performance Tracker.
Keeping Track Of Review Designations: BTDs For X4, F2G, And BMS; Another QIDP For Allergan
The latest news about products accepted into US FDA expedited review programs.
Keeping Track Of User Fee Decisions And Filings: Adakveo, Brukinsa And Fetroja Mark Massive Week Of Novel Approvals
The latest news on US FDA user fee decisions and submissions to the agency.