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June 02, 2025 07:05 ET | Source: uniQure Inc.

uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease

~ Alignment with FDA continues to support Accelerated Approval pathway ~ ~ BLA submission planned for first quarter of 2026 ~ ~ Conference call today at 8:30 a.m. ET ~ LEXINGTON, Mass. and...
December 04, 2023 16:05 ET | Source: Travere Therapeutics, Inc.

Travere Completes Successful pre-NDA Meeting for FILSPARI in IgAN; Provides Regulatory Updates for both IgAN and FSGS

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...
October 03, 2023 16:05 ET | Source: SeaStar Medical Holding Corporation

SeaStar Medical Provides Regulatory Update Regarding Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption

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...
May 04, 2023 08:30 ET | Source: Veru Inc.

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

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...
November 29, 2018 08:30 ET | Source: Histogenics Corporation

Histogenics and FDA Continue to Discuss NeoCart® Phase 3 Clinical Trial Data and Potential Regulatory Pathway

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...
November 01, 2018 16:05 ET | Source: Histogenics Corporation

Histogenics and FDA to Continue Discussions on NeoCart Phase 3 Clinical Trial Data and Potential Regulatory Pathway

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...
January 02, 2018 08:30 ET | Source: Cascadian Therapeutics, Inc.

Cascadian Therapeutics Receives Pediatric Investigation Plan Waiver from the European Medicines Agency

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...