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Michael Cipriano

Washington, DC
Michael Cipriano is a writer based in Washington, D.C. who covers FDA regulatory policy. He has primarily written about advisory committees, FDA public meetings and drug regulation. He is also part of the Pink Sheet’s efforts to expand coverage into Latin America. Previously, Michael has covered generic drug and biosimilar regulation, as well as issues impacting clinical trials.

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.

Drug Review Profile Cancer

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.

Drug Review Profile Cancer

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.

Drug Review Profile Cancer

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.

Leadership Biosimilars

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.

Leadership Biosimilars

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.

US FDA Performance Tracker Approvals
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