Areas of Expertise Regulation Drug Review Research & Development
Industry Experience BioPharmaceutical
Writes for Pink Sheet Scrip
Latest From Michael Cipriano
Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data
After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.
Xpovio Clinical Development Timeline
Chronicle of the development and review of Karyopharm's Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies.
Xpovio's US FDA Review: A Primer On How (Not) To Submit Real-World Data
Karyopharm included a real-world data study to support its Xpovio NDA, but the US FDA deemed the study inadequate for an overall survival comparison to the pivotal STORM trial.
FDA's Yim Wants US To Emulate Europe On Biosimilars
In an exclusive interview with Generics Bulletin sister publication the Pink Sheet, the now-permanent OTBB director Sarah Yim discussed her expectations for the future of the US biosimilars market, her learning experience as acting director and upcoming challenges for her office.
US FDA's Yim Hopes To See European-Like Robustness For US Biosimilars Market In 10 Years
In an exclusive interview with the Pink Sheet, the now-permanent OTBB director Sarah Yim discussed her expectations for the future of the US biosimilars market, her learning experience as acting director and upcoming challenges for her office.
Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.