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FDA General
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Waiting for the results of the SRP-9001 confirmatory trial may be a better move
Upadacitinib lands indication for moderately to severely active disease in adults
Agency reviewers signal little support for first potential nonalcoholic steatohepatitis drug
Whether vote means FDA will approve Sarepta's gene therapy remains to be seen
First-in-class drug works by blocking the NK3 receptor, which plays role in regulating body temp
Measure does not address scheduling the drug, which is frequently added to fentanyl
New language emphasizes potential for misuse, abuse, addiction, and overdose
Choice of alternative route with nasal spray outweighs possible risks, panelists say
Better prediction of shortages and more inspections of foreign plants are critical, experts say
New guidance ditches MSM-specific screening questions in effort to expand eligibility
Boxed warning on increased mortality risk in elderly patients remains for brexpiprazole
"Benefits are large, and the drug is incredibly effective," says advisory committee chair
Agency reviewers question micro-dystrophin as a surrogate endpoint
