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September 06, 2026 21:19 ET | Source: Rezubio Pharmaceuticals Co., Ltd

Rezubio Announces FDA and NMPA IND Clearances and First Cohort Dosing of RZ-520, a Novel Inhaled Therapy for Chronic Respiratory Diseases

Rezubio announces clearances of FDA and NMPA and first participant dosing of RZ-520
August 11, 2026 07:00 ET | Source: AC Immune SA

AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD)

AC Immune receives Fast Track designation and IND clearance from the FDA for anti-alpha-synuclein active immunotherapy to treat early Parkinson's disease
November 29, 2023 07:05 ET | Source: uniQure Inc.

uniQure Announces FDA Clearance of Investigational New Drug Application for AMT-191 Gene Therapy for Fabry Disease

LEXINGTON, Mass. and AMSTERDAM, Nov. 29, 2023 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical...
September 05, 2023 07:05 ET | Source: uniQure Inc.

uniQure Announces FDA Clearance of Investigational New Drug Application for AMT-260 Gene Therapy for Refractory Mesial Temporal Lobe Epilepsy

LEXINGTON, Mass. and AMSTERDAM, Sept. 05, 2023 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical...
July 24, 2023 09:00 ET | Source: Molecure

The U.S. Food and Drug Administration Gives the Green Light to Molecure’s Flagship Program – Phase II Clinical Testing of OATD-01 is Ready for Launch

Press release The U.S. Food and Drug Administration Gives the Green Light to Molecure’s Flagship Program – Phase II Clinical Testing of OATD-01 is Ready for Launch Molecure can proceed with clinical...
November 04, 2021 08:00 ET | Source: Neurona Therapeutics

Neurona Therapeutics Receives IND Clearance to Initiate Phase 1/2 Clinical Trial of Neural Cell Therapy NRTX-1001 in Chronic Focal Epilepsy Patients

SAN FRANCISCO, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a biotherapeutics company advancing restorative neural cell therapies for the treatment of chronic neurological disorders,...
January 27, 2020 16:05 ET | Source: Surface Oncology, Inc.

Surface Oncology Announces FDA Clearance of SRF617 and SRF388 INDs to Initiate Phase 1 Clinical Trials

Company focuses efforts and resources on advancing SRF617 and SRF388; Implements strategic restructuring Initial clinical updates for SRF617 and SRF388 expected by the end of 2020 Extends current...
August 12, 2019 07:00 ET | Source: ProQR Therapeutics N.V.

ProQR Announces Clearance of IND to Start Clinical Trial of QR-1123 in Patients with Autosomal Dominant Retinitis Pigmentosa (adRP)

LEIDEN, Netherlands and CAMBRIDGE, Mass., Aug. 12, 2019 (GLOBE NEWSWIRE) -- ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of...
January 22, 2019 07:00 ET | Source: uniQure Inc.

uniQure Announces FDA Clearance of Investigational New Drug Application for AMT-130 in Huntington’s Disease

~ AMT-130 Poised to Become First AAV Gene Therapy to Enter the Clinic for Huntington’s Disease ~ ~ Lead Product Candidate from Company’s Proprietary miQURE™ Gene Silencing Platform ~ LEXINGTON,...
December 04, 2018 07:00 ET | Source: ProQR Therapeutics N.V.

ProQR Announces Clearance of IND to Start Clinical Trial of QR-421a in Usher Syndrome Type 2 Patients

LEIDEN, Netherlands & CAMBRIDGE, Mass., Dec. 04, 2018 (GLOBE NEWSWIRE) -- ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA...