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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.
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Latest From Michael Cipriano

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

US FDA Drug Risk Management Board To Be Lead By CDER Deputy Cavazzoni

CDER Director Woodcock announced that the drug center will soon launch the Drug Risk Management Board, which will coordinate product safety activities among the different offices; Patrizia Cavazzoni, who serves as CDER's deputy director of operations, will chair the board.

Drug Safety FDA

Keeping Track: Nektar Withdraws Oxycodegol NDA As Novel Submission Pileup Continues

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Drug Review

Nektar's Novel Opioid Unanimously Rejected by US FDA Advisory Cmte.

But more data on abuse potential and efficacy could offer path for forward for oxycodegol even after the FDA product-specific advisory committee meeting for an opioid analgesic in more than a year goes very badly for the sponsor.

Advisory Committees Neurology
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