Fast Track – Talk Bio

Recent Advances and News in In Vivo Therapeutic Technologies (2025)

1 week ago talkbio0Tagged Acquisitions, Autoimmune Diseases, CAR-T, Cell Therapy, drug delivery innovation, Fast Track, gene therapy, in vivo, nanoparticle delivery, Neoplasms, RNA delivery, United States Food and Drug Administration

in vivo CAR-T; cell therapy; gene therapy; RNA delivery; autoimmune disease; oncology; nanoparticle delivery; drug delivery innovation; FDA fast track; biotech acquisitions

Ionis Heads to FDA as Antisense Therapy Aces Pivotal Study in Rare Neurological Disease

1 month ago talkbio0Tagged access program, Alexander Disease, Antisense Oligonucleotides, Fast Track, Identifier, Improvement, Infrequent, Ionis Pharmaceuticals, nervous system disorder, orphan drug designation, Phase I – III study, Speed, United States Food and Drug Administration, Zilganersen

Ionis Pharmaceuticals; zilganersen; antisense oligonucleotide; Alexander disease; pivotal Phase I–III study; FDA Fast Track designation; rare neurological disease; expanded access program; walk speed improvement; Orphan Drug designation

Corcept’s ALS Drug Trial Misses Primary Endpoint, Yet Shows Promising Survival Benefit

11 months ago talkbio0Tagged Amyotrophic Lateral Sclerosis, Benefit, Corcept, Cortisol modulator, dazucorilant, Fast Track, Identifier, Phase 2 trial, Survival

Corcept Therapeutics, Dazucorilant, ALS (Amyotrophic Lateral Sclerosis), Phase 2 trial, Survival benefit, Fast Track Designation, Cortisol modulator