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The FDA has approved the first over-the-counter (OTC) naloxone nasal spray — Emergent BioSolutions’ opioid overdose therapy Narcan, 4 mg — and is encouraging other producers to apply for OTC status. Read More
The FDA has told Incyte that it can’t review the company’s new drug application (NDA) for Janus kinase inhibitor Jakafi (ruxolitinib) extended-release (XR) tablets without more supporting data. Read More
The FDA said it could not approve AbbVie’s new drug application (NDA) for ABBV-951 (foslevodopa/foscarbidopa), an investigational therapy for advanced Parkinson’s disease, because of concerns about the delivery device. Read More