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February 11, 2025 07:01 ET | Source: Travere Therapeutics, Inc.

Travere Therapeutics to Submit sNDA for FILSPARI® (sparsentan) in FSGS

Company completed Type C meeting with FDA, aligning on its plan to submit an sNDA; submission expected around end of 1Q25
December 16, 2024 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis Submits ZORYVE® (roflumilast) Cream 0.05% Supplemental New Drug Application to the FDA for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis

Arcutis today announced the submission of an sNDA to the FDA for ZORYVE (roflumilast) cream 0.05% for children aged 2 to 5 for mild to moderate AD.
December 12, 2024 06:59 ET | Source: Sobi, Inc.

Sobi Announces FDA Acceptance of New Drug Application for Avatrombopag (DOPTELET®) for the Treatment of Pediatric Immune Thrombocytopenia

WALTHAM, Mass., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced that the U.S. Food and Drug Administration...
September 24, 2024 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

FDA Accepts Arcutis’ Supplemental New Drug Application for ZORYVE® (roflumilast) Foam for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over

Arcutis today announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3% for scalp and body psoriasis.
July 23, 2024 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over

Arcutis today announced the submission of an sNDA in scalp and body psoriasis.
March 15, 2024 15:34 ET | Source: Optinose, Inc.

XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps

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...
March 11, 2024 07:05 ET | Source: Travere Therapeutics, Inc.

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)

Travere announces submission of an sNDA to the FDA for conversion of existing US accelerated approval of FILSPARI (sparsentan) in IgAN to full approval.
March 07, 2024 07:00 ET | Source: Optinose, Inc.

Optinose Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights

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...
February 29, 2024 16:40 ET | Source: Optinose, Inc.

Optinose Announces Reporting Date for Fourth Quarter 2023 Financial Results

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...
December 06, 2023 07:00 ET | Source: Optinose, Inc.

Optinose Announces 3-Month Extension of FDA Review Period for the Supplemental New Drug Application for XHANCE

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 ...

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