The US Food and Drug Administration (FDA) has granted Fast Track Designation to Complement Therapeutics’ CTx001, the ...
Designation earned for one-time AAV gene therapy SAR446268, designed to silence DMPK expression Myotonic dystrophy type 1 (DM1) is a rare, genetic disorder that causes progressive muscle weakness and ...
Fast Track designation granted by U.S. FDA for evaluation of ETX-19477 in patients with BRCA-mutated, platinum-resistant ...
Company enters 2026 with over $70 million in cash, two positive Phase 2 programs, FDA Fast Track Designation and runway well into 2027MELBOURNE, Australia and NEW YORK, Jan. 14, 2026 (GLOBE NEWSWIRE) ...
STAFFORD, Texas, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01 ...
MapLight Therapeutics (MPLT) announced that the U.S. Food and Drug Administration has granted Fast Track designation to ML-007C-MA, an ...
TT125-802 is a small molecule CBP/p300 bromodomain inhibitor that shows clinical activity as single agent in solid tumors, including advanced EGFR-mutated and KRAS-G12C-mutated non-small cell lung ...
GondolaBio Receives U.S. FDA Orphan Drug and Fast Track Designations for PORT-77 for the Treatment of Erythropoietic Protoporphyria (EPP) and X-Linked Protoporphyria (XLP) - PORT-77 has the potential ...
Ultragenyx Pharmaceutical (RARE) has completed the rolling submission of its U.S. marketing application for its gene therapy ...
SHANGHAI, Aug. 6, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that ...
US FDA grants fast track designation to Complement Therapeutics’ gene therapy candidate CTx001 to treat geographic atrophy: Munich Saturday, January 10, 2026, 17:00 Hrs [IST] Co ...
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