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
16 déc. 2024 08h00 HE
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Arcutis Biotherapeutics, Inc.
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.
Sobi Announces FDA Acceptance of New Drug Application for Avatrombopag (DOPTELET®) for the Treatment of Pediatric Immune Thrombocytopenia
12 déc. 2024 06h59 HE
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Sobi, Inc.
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...
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
24 sept. 2024 08h00 HE
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Arcutis Biotherapeutics, Inc.
Arcutis today announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3% for scalp and body psoriasis.
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
23 juil. 2024 08h00 HE
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Arcutis Biotherapeutics, Inc.
Arcutis today announced the submission of an sNDA in scalp and body psoriasis.
XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
15 mars 2024 15h34 HE
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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)
11 mars 2024 07h05 HE
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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
07 mars 2024 07h00 HE
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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
29 févr. 2024 16h40 HE
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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
06 déc. 2023 07h00 HE
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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
09 nov. 2023 07h00 HE
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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...