Upcoming goal dates for Emergent’s Narcan and Harm Reduction Therapeutics’ RiVive will test the US FDA’s efforts to nurture the over-the-counter naloxone switch, followed by decisions on higher strength nasal opioid antagonist products from Opiant and Orexo to address fentanyl and other synthetic opioids. 

Upcoming goal dates for Emergent’s Narcan and Harm Reduction Therapeutics’ RiVive will test the US FDA’s efforts to nurture the over-the-counter naloxone switch, followed by decisions on higher strength nasal opioid antagonist products from Opiant and Orexo to address fentanyl and other synthetic opioids. 

Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year. 

JAMA reports on the COVID-19 Prevention Network’s efforts. Also, Inhibikase said the US FDA lifted a hold on its drug for Parkinson’s disease, while Astellas Pharma said the agency lifted a clinical hold on its gene therapy for Pompe disease. And Trefoil, Theriva Biologics and Nektar initiated new trials.