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Agency Actions

Benefits of opioid addiction treatment outweigh risks of adverse effects
Patient deaths related to other combination therapies concern the agency
Panel believes GSK’s Shingrix represents an improvement over Merck’s Zostavax
Support will strengthen state efforts to prevent and track opioid overdoses
Cell-based therapy harvests, cultures, and applies allogeneic thymic tissue
Pegylated interferon lambda 1a stimulates immune responses
Phase 3 clinical trials in patients with severe PTSD to begin in 2018
Orphan drug and fast-track status underscore significant unmet need for therapy
Agency cites “troubling products” being marketed in Florida and California