November 3, 2025 – Talk Bio

uniQure Faces Delay as FDA Walks Back Accelerated Approval for Huntington’s Gene Therapy

13 hours ago talkbio0Tagged Accelerated, AMT-130, Approved, Clinical Trials, gene therapy, Huntington 's disease, Regulatory Setback, UniQure, United States Food and Drug Administration

uniQure; AMT-130; Huntington’s disease; gene therapy; FDA; accelerated approval; regulatory setback; clinical trial

Roche Pays $55M Upfront to Manifold Bio in $2B+ Deal for AI-Guided Next-Gen Brain Shuttles

17 hours ago talkbio0Tagged AI drug discovery, BBB, Blood - brain barrier anatomy, Manifold Bio, milestones, Neurological diseases, research, Roche (company), shuttles, therapeutic payloads, upfront payment

Roche; Manifold Bio; blood-brain barrier; BBB shuttles; neurological diseases; AI drug discovery; research deal; upfront payment; milestones; therapeutic payloads

‘Trying to take me out’: Tidmarsh’s exit at FDA pushes an agency in transition toward turmoil

22 hours ago talkbio0Tagged agency turmoil, Center for Drug Evaluation, Center for Drug Evaluation and Research, George Tidmarsh, Kevin Tang, Leadership, personal conduct probe, Regulatory Authority, research, resignation, United States Food and Drug Administration

FDA; George Tidmarsh; resignation; personal conduct probe; Kevin Tang; Center for Drug Evaluation and Research (CDER); agency turmoil; Vinay Prasad; leadership transitions; regulatory authority