FDA General

Further discussion about first-in-human trials is ongoing

Agency asks drugmaker for a repeat-dose study before approval

Advisory committee to weigh in on safety concerns with GLP-1 receptor agonist implant

In multinational cohort, cancer incidence with pulled drug no different than other H2RAs

In a phase III trial, momelotinib reduced anemia, constitutional symptoms, and splenomegaly

The Pediatric Advisory Committee will discuss if data support a safe first-in-human trial

A total of 301 drugs were in active shortage last year

Clinical meaningfulness is a different question, however

A singular narrative, consistency, and relatability are paramount

Walgreens and CVS among companies accused of marketing products with "heightened risk of harm"

Unanimous vote that the drug is ineffective

Device designed to prevent amputation in chronic limb-threatening ischemia

Motixafortide plus filgrastim increased adequate harvest rate from 9.5% to 67.5%

New single-strain vaccines will exclusively target the XBB.1.5 Omicron subvariant