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 »
A panel of independent experts advising the Centers for Disease Control and Prevention (CDC) plans to consider additional doses of COVID-19 vaccine in a small fraction of the population with weakened immune systems. The Advisory Committee on Immunization Practices (ACIP) plans to convene on July 22 to discuss “clinical considerations for additional doses in immunocompromised… Read More »
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 »