XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
March 15, 2024 15:34 ET
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Optinose, Inc.
ReOpen was the first ever large placebo-controlled clinical trial program to demonstrate statistically significant reduction of symptoms in chronic sinusitis patients without nasal polyps Clinical...
Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN)
March 11, 2024 07:05 ET
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Travere Therapeutics, Inc.
Travere announces submission of an sNDA to the FDA for conversion of existing US accelerated approval of FILSPARI (sparsentan) in IgAN to full approval.
Optinose Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights
March 07, 2024 07:00 ET
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Optinose, Inc.
PDUFA target action date is March 16, 2024, for the Company's sNDA. If approved, the Company is prepared for launch of XHANCE for treatment of patients diagnosed with chronic sinusitis Physicians...
Optinose Announces Reporting Date for Fourth Quarter 2023 Financial Results
February 29, 2024 16:40 ET
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Optinose, Inc.
YARDLEY, Pa., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced...
Optinose Announces 3-Month Extension of FDA Review Period for the Supplemental New Drug Application for XHANCE
December 06, 2023 07:00 ET
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Optinose, Inc.
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 ...
Optinose Reports Third Quarter 2023 Financial Results and Operational Updates
November 09, 2023 07:00 ET
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Optinose, Inc.
Company reports third quarter 2023 XHANCE net revenue of $19.8 million and increases full year 2023 XHANCE net revenue guidance Strong improvement in operating efficiency as SG&A and R&D...
Arcutis Submits Roflumilast Cream 0.15% Supplemental New Drug Application to the FDA for the Treatment of Atopic Dermatitis in Adults and Children Ages 6 Years and Older
September 12, 2023 07:30 ET
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Arcutis Biotherapeutics, Inc.
Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United StatesIn pivotal Phase 3 trials, roflumilast cream demonstrated...
Arcutis Announces First Quarter 2023 Financial Results and Provides Business Update
May 09, 2023 16:02 ET
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Arcutis Biotherapeutics, Inc.
Achieved net revenues of $2.8 million for ZORYVE® (roflumilast) cream 0.3% in the first quarter of 2023, with unit demand growth nearly doubling quarter-over-quarterContinued expansion of commercial...
Arcutis Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
February 28, 2023 16:02 ET
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Arcutis Biotherapeutics, Inc.
Achieved net revenues of $3.0 million for ZORYVE® (roflumilast) cream 0.3% in the first full quarter since the August 2022 launch, driven by continued unit demand growthSecured expanded commercial...
Optinose Announces CEO Transition and Business Update
January 31, 2023 07:00 ET
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Optinose, Inc.
YARDLEY, Pa., Jan. 31, 2023 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced...