FDA Clears Graviton BioScience's GV101 for Phase 2 Development in Friedreich's Ataxia
Graviton BioScience has received FDA IND clearance for a new GV101 capsule formulation, paving the way for a Phase 2 trial in patients with Friedreich’s ataxia.
Clinical-stage Biotechnology Company | 12/08/2026 | By News Bureau | 316
4Moving Biotech has completed patient enrollment in its global Phase 2a INFLAM MOTION trial, assessing the safety and efficacy of investigational therapy 4P004 for inflammatory knee osteoarthritis.
Clinical-stage Biotechnology Company | 05/08/2026 | By News Bureau | 1303
Dyne Therapeutics' Duchenne Muscular Dystrophy Therapy Receives FDA Priority Review
FDA accepts Biologics License Application for investigational exon 51-skipping therapy z-rostudirsen, with a regulatory decision expected by January 2027.
Clinical-stage Biotechnology Company | 22/07/2026 | By News Bureau
Can-Fite BioPharma Secures Australian Patent for Namodenoson in Advanced Metastatic Cancer
Can-Fite BioPharma has secured an Australian patent covering the use of Namodenoson for advanced metastatic cancer, strengthening intellectual property protection as the drug advances through late-stage clinical development for liver and pancreatic cancers.
Clinical-stage Biotechnology Company | 15/07/2026 | By News Bureau
Immunomic Therapeutics Doses First Patient in Phase 1 Trial of Japanese Cedar Allergy Vaccine
Immunomic Therapeutics has initiated Phase 1 clinical testing of ITI-9001 after dosing the first participant in Japan, advancing the development of a next-generation therapeutic vaccine for Japanese cedar pollen allergy.
Clinical-stage Biotechnology Company | 06/07/2026 | By News Bureau | 103
INTENT Biologics Secures FDA Breakthrough Therapy Tag for Diabetic Foot Ulcer Treatment Candidate
INTENT Biologics' PEP Biologic receives FDA Breakthrough Therapy designation for diabetic foot ulcers, accelerating development of its first-in-class exosome-based regenerative treatment aimed at improving healing outcomes in chronic wounds.
Clinical-stage Biotechnology Company | 03/07/2026 | By News Bureau | 233
Aplagon Doses First Patient in Phase IIa Trial of APAC for Chronic Limb-Threatening Ischemia
Aplagon has dosed the first patient in its Phase IIa HEALING trial evaluating APAC therapy for Chronic Limb?Threatening Ischemia caused by Peripheral Arterial Occlusive Disease in Finland.
Clinical-stage Biotechnology Company | 16/03/2026 | By News Bureau | 167
TaiGen Biotechnology doses first participant in Phase I trial of ISM4808, an AI-designed oral therapy from Insilico Medicine for chronic kidney disease-related anemia.
Clinical-stage Biotechnology Company | 09/03/2026 | By News Bureau | 266
Seaport Therapeutics receives up to USD 15 million from ARPA-H to develop GlyphCele, a lymphatic-targeted oral therapy designed to treat metabolic disease and pancreatic cancer by restoring gut lymphatic function.
Clinical-stage Biotechnology Company | 06/03/2026 | By News Bureau | 235
Diakonos Oncology Phase II Glioblastoma Trial Cleared to Continue After DSMB Safety Review
Independent safety review clears Diakonos Oncology’s Phase II DOC1021 glioblastoma trial to proceed, with no safety concerns identified to date.
Clinical-stage Biotechnology Company | 18/02/2026 | By News Bureau | 217
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