FDA Grants R3 Vascular IDE Approval for ELITE-BTK Pivotal Trial of its MAGNITUDE® Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease
November 04, 2024 06:00 ET
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R3 Vascular
MOUNTAIN VIEW, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) -- R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating...
SeaStar Medical Announces that Stanford Medicine is Cleared to Actively Enroll Subjects in the Adult Acute Kidney Injury Pivotal Trial
October 23, 2024 08:30 ET
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SeaStar Medical Holding Corporation
DENVER, Oct. 23, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of...
Journal of the American Academy of Dermatology Publishes ZORYVE (roflumilast) Foam, 0.3% Results for Seborrheic Dermatitis from Pivotal Phase 3 Trial
January 29, 2024 08:00 ET
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Arcutis Biotherapeutics, Inc.
Arcutis today announced that JAAD published positive results from the pivotal Phase 3 STRATUM trial evaluating ZORYVE (roflumilast) foam, 0.3%.
Arcutis Presents Positive Patient-Reported Outcome Data from the Pivotal ARRECTOR Phase 3 Trial in Scalp and Body Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress
October 13, 2023 08:00 ET
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Arcutis Biotherapeutics, Inc.
Arcutis announced new data from its pivotal ARRECTOR Phase 3 trial of roflumilast foam 0.3% for treatment of adults/adolescents with scalp/body psoriasis.
Arcutis Announces Positive Results from INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
September 19, 2023 07:30 ET
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Arcutis Biotherapeutics, Inc.
Study met the primary endpoint and all secondary endpoints, highly consistent with rapid response from the INTEGUMENT-1 and INTEGUMENT-2 pivotal trialsFor the primary endpoint, 25.4% of children...
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 Completes Enrollment in INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
May 02, 2023 08:00 ET
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Arcutis Biotherapeutics, Inc.
A total of 652 children, ages 2 to 5, were enrolled in the studyTopline data expected in the third quarterAtopic dermatitis (AD) affects approximately 26 million adults and children in the United...
The Insulin-Only Bionic Pancreas Pivotal Trial Showed Consistent Mean HbA1c Reductions Across a Variety of Subgroups at ADA’s 82nd Scientific Sessions
June 09, 2022 14:00 ET
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Beta Bionics, Inc.
Caution: The iLet® Bionic Pancreas is an investigational device limited by Federal (or United States) law to investigational use. Not available for sale. The randomized Insulin-Only Bionic Pancreas...
Arcutis Announces Positive Topline Results from STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis
June 06, 2022 07:30 ET
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Arcutis Biotherapeutics, Inc.
Study met its primary endpoint with 80.1% of individuals treated with roflumilast foam achieving Investigator Global Assessment (IGA) Success compared to 59.2% of patients treated with vehicle...