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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

Cefiderocol Approval Likely After Panel Vote, But Future Still Clouded

Shionogi's cUTI drug clears US FDA advisory committee by 14-2, though a black box warning is possible after one of the clinical studies showed a potential mortality imbalance disfavoring cefiderocol in other diseases.

Advisory Committees Infectious Diseases

US FDA's Temple On Real-World Evidence: 'I Find The Whole Thing Very Frustrating'

CDER deputy director for clinical science reiterates his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims.

Drug Approval Standards Post Market Regulation & Studies

Possible Mortality Imbalance For Shionogi's Cefiderocol On US FDA Panel Agenda

Although cefiderocol demonstrated safety and efficacy in a pivotal trial for complicated urinary tract infections, there was a mortality imbalance between the study drug and comparator arms in a separate descriptive trial; the US FDA is unsure whether the imbalance was a "chance finding."
Advisory Committees Infectious Diseases

Keeping Track: Scenesse, Reyvow, and Beovu Make Trio Of Novel Approvals

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

US FDA Performance Tracker Approvals

International Pricing Index Could Suffer From Industry Gaming

Former US FDA commissioner Scott Gottlieb doesn't "want to give too much away," but expresses skepticism about Trump administration's ability to implement its international price index proposal, noting there are ways for brand companies to game the system.

Pricing Debate Reimbursement

Keeping Track: US FDA, Industry Roar Into Fourth Quarter With Bevy Of Regulatory Announcements

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

US FDA Performance Tracker Approvals
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