Tag Archives: Panel

AstraZeneca, FibroGen hit another roxadustat setback as FDA panel calls for more safety data

AstraZeneca and its roxadustat partner FibroGen headed into a high-stakes FDA expert meeting this week after receiving tough safety questions about the med from agency staffers. The daylong event Thursday featured bruising feedback, and their application now faces even more uncertainty. In a 13 to 1 vote, FDA committee panelists said that the drug should not be approved… Read More »

House panel to hold hearing on VA delay of first EHR go-live

The chair of the House subcommittee charged with legislative oversight of the VA’s Cerner electronic health record implementation is concerned about the agency’s decision to delay the EHR’s initial go-live. “I’m concerned that as we’ve moved closer to the go-live date, we have been told repeatedly that there were no showstoppers in the implementation, that… Read More »

CDC panel endorses Pfizer’s Covid vaccine for use in adolescents, clearing way for shots to begin Thursday

A Centers for Disease Control and Prevention advisory panel voted Wednesday to endorse expanded usage of Pfizer‘s and BioNTech‘s Covid-19 vaccine for 12- to 15-year-old kids, clearing the way for pediatricians to start giving out the shots across the U.S. as early as Thursday. The Advisory Committee on Immunization Practices’ recommendation, which was adopted 14-0 with one… Read More »