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Latest From Ramsey Baghdadi
Safety notice for Merck's Keytruda in multiple myeloma had some notable elements – from what comes next to who delivered the message.
US FDA’s top cancer drug reviewer has been uncharacteristically quiet during recent advisory committee meetings. That just changed, and the result may not have been great for the sponsor (Pfizer), but it is a reminder of the value that Pazdur’s institutional knowledge and outspokenness bring to all of FDA.
Conflict of interest waivers for US FDA advisory committee review of sunitinib's supplemental application signal that difference in statistical analyses for disease-free survival could be key area of discussion.
The White House missed an opportunity to tout a major legislative accomplishment in the first year of President Trump’s term.
Sponsors are seeking US “Breakthrough Therapy” Designations at a record pace in FY 2017.
Next CAR-T in line at US FDA, Kite’s axicabtagene ciloleucel, looks headed toward an early approval with the agency confirming no panel will be scheduled, according to the firm. But the company and FDA may have benefited from an advisory committee review.