Lofexidine Gets US FDA Panel Nod For Mitigating Opioid Withdrawal Symptoms
But Psychopharmacologic Drugs Advisory Committee says US WorldMeds' second proposed indication for facilitating completion of opioid discontinuation treatment is not supported by data from two short-term studies in an 'idealized' population.
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Keeping Track: A Diverse Array Of Approvals, A CRL For Evolus' Botox Competitor, And Coherus Refiles Neulasta Biosimilar
The latest drug development news and highlights from our US FDA Performance Tracker.
Aimovig, Andexxa, Lucemyra, and pegvaliase are among the almost 20 products with upcoming user fee goals at US FDA this month.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.