YARDLEY, Pa., April 25, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced...
YARDLEY, Pa., April 04, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced...
Updated: FDA expands label for nasal spray to treat chronic sinus inflammation
XHANCE Approved by FDA as First and Only Medication for Chronic Rhinosinusitis
Optinose Reports Fourth Quarter and Full Year 2023 Financial Results
Optinose Announces Reporting Date for Fourth Quarter 2023 Financial Results
XHANCE significantly reduced both symptoms and sinus opacification in participants with chronic sinusitis (chronic rhinosinusitis) in two randomized controlled Phase 3 Clinical Trials (ReOpen1 and...
YARDLEY, Pa., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review period of its supplemental new drug application (sNDA) requesting approval of XHANCE as a treatment for chronic rhinosinusitis. The updated Prescription Drug User Fee Act (PDUFA) goal date is March 16, 2024.
The application is based on phase 3 results from the ReOpen clinical trial program showing XHANCE significantly reduced symptoms and sinus opacification in participants with chronic rhinosinusitis ...
YARDLEY, Pa., Nov. 22, 2023 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced...