Travere Completes Successful pre-NDA Meeting for FILSPARI in IgAN; Provides Regulatory Updates for both IgAN and FSGS
December 04, 2023 16:05 ET
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Travere Therapeutics, Inc.
After meeting with the FDA, Company to submit a supplemental New Drug Application (sNDA) to FDA in Q1 2024 for conversion of the existing U.S. accelerated approval of FILSPARI® (sparsentan) in IgAN to...
SeaStar Medical Provides Regulatory Update Regarding Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption
October 03, 2023 16:05 ET
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SeaStar Medical Holding Corporation
Company to finalize labeling with FDA Approvable Letter expected within a month DENVER, Oct. 03, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device...
Veru Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin Treatment of Hospitalized COVID-19 Adult Patients at High Risk for ARDS
May 04, 2023 08:30 ET
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Veru Inc.
Reached agreement with FDA on confirmatory Phase 3 clinical trial design in 408 subjects with primary endpoint of all-cause mortality at Day 60 Study to expand treatment population to include all...
Histogenics and FDA Continue to Discuss NeoCart® Phase 3 Clinical Trial Data and Potential Regulatory Pathway
November 29, 2018 08:30 ET
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Histogenics Corporation
WALTHAM, Mass., Nov. 29, 2018 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain...
Histogenics and FDA to Continue Discussions on NeoCart Phase 3 Clinical Trial Data and Potential Regulatory Pathway
November 01, 2018 16:05 ET
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Histogenics Corporation
WALTHAM, Mass., Nov. 01, 2018 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain...
Cascadian Therapeutics Receives Pediatric Investigation Plan Waiver from the European Medicines Agency
January 02, 2018 08:30 ET
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Cascadian Therapeutics, Inc.
SEATTLE, Jan. 02, 2018 (GLOBE NEWSWIRE) -- Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, today announced that it received a product-specific pediatric...