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FDA Panel: Tolerating Approval Outliers Would Set Dangerous Precedent

FDA panel urges Acrotech to speed up study on cancer drugs

A panel of independent experts to the U.S. health regulator urged Acrotech Biopharma to work with the agency to bring forward the date for releasing trial data that could confirm benefits of the.

FDA panel urges Acrotech to speed up study on cancer drugs

The drugs, Folotyn and Beleodaq, have already been on the market for nearly a decade or more. "We would like the FDA and sponsor to strategize about other possible ways to have a shorter study readout than waiting another seven years from now," the panel's acting chairperson Andy Chen said on Thursday. The company's final study plan was submitted to the FDA in 2022 and is expected to be completed by 2030, according to FDA briefing documents published earlier this week.

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