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FDA General
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Yet advisors were not inclined to take back approval for bleeding reversal agent
No one is saying for certain; a final rule is in process but has yet to be issued
New antibody indicated for previously treated, unresectable or metastatic HER2-positive disease
Panel wants to reduce barriers to the only drug indicated for treatment-resistant schizophrenia
One expert believes we're returning to "every man his own doctor"
Complete responses in 21% of patients treated with single-agent revumenib
Can severe neutropenia associated with the schizophrenia drug be monitored without it?
Health news and commentary gathered by staff
Novel treatment is indicated for children and adults with the rare disorder
Agency spent over 15 years crafting the guidelines
Agency's decision on obeticholic acid in PBC follows negative advisory committee meeting
Advocates look to undo Biden administration's policies
Obecabtagene autoleucel has no requirement for a REMS program
