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Califf Nomination Swimming Upstream With Multiple Holds Now Possible

 
• By Derrick Gingery

Two Senators could place holds on Robert Califf's nomination for FDA commissioner as HELP Committee sends it to the floor.

Robert Califf's fish story has yet to conclude and now may require a prominent place on his agenda if confirmed as FDA commissioner.

Califf received a unanimous vote from the Senate Health, Education, Labor and Pensions Committee Jan. 12 to become the next FDA commissioner. But it is now expected that his name...

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STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.