August 18, 2025 – Talk Bio

Conflicts of Interest Among Federal Vaccine Advisors at Historic Lows Through 2024

5 days ago talkbio0Tagged ACIP, Advisory Committees, Centers for Disease Control and Prevention (U.S.), JAMA study, Robert F. Kennedy Jr., Translucent, United States Food and Drug Administration, Vaccines, VRBPAC

conflicts of interest; vaccine advisory committees; ACIP; VRBPAC; CDC; FDA; transparency; Robert F. Kennedy Jr.; JAMA study

FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years

5 days ago talkbio0Tagged Analgesics, Non-Narcotic, Approved, Chronic pain, Clinical Trials, cyclobenzaprine, Fibromyalgia, Hairy Cell Leukemia, Phase 3, sublingual tablets, Tonix, Tonmya, United States Food and Drug Administration

Tonmya; FDA approval; fibromyalgia; Tonix Pharmaceuticals; non-opioid analgesic; cyclobenzaprine HCl sublingual tablets; chronic pain; phase 3 clinical trials

FDA Grants Wegovy 3rd Indication: First GLP-1 Approved for MASH with Moderate-to-Advanced Liver Scarring

5 days ago talkbio0Tagged Accelerated, Approved, Fibrosis, Liver, MASH, noncirrhotic, Nordisk, Product containing glucagon-like peptide 1 receptor agonist (product), semaglutide, United States Food and Drug Administration, Wegovy

Wegovy; FDA approval; MASH; semaglutide; GLP-1 receptor agonist; liver fibrosis; Novo Nordisk; ESSENCE trial; noncirrhotic; accelerated approval

Merck KGaA Forms $2 Billion Neurological Disease Pact with Skyhawk Therapeutics

5 days ago talkbio0Tagged Drug Discovery, Merck KGaA, milestone payments, Neurological diseases, RNA Splicing, Skyhawk, SkySTAR platform, strategic collaboration

Merck KGaA; Skyhawk Therapeutics; neurological diseases; RNA splicing; SkySTAR platform; drug discovery; strategic collaboration; milestone payments

Genentech to End $2B Cell Therapy Collaboration with Adaptive Biotechnologies

5 days ago talkbio0Tagged Adaptive Biotechnologies, Cell Therapy, Collaboration termination, genentech, personalized cancer, T-Cell Receptor, TruTCR

Genentech; Adaptive Biotechnologies; cell therapy; collaboration termination; T-cell receptor; TruTCR platform; personalized cancer therapy; $2 billion deal

FDA Delays Draw Contrasting Responses: Neurizon Cites Agency Strain, Omeros Takes Softer Tone

5 days ago talkbio0Tagged agency staffing shortages, Amyotrophic Lateral Sclerosis, delays, narsoplimab, NUZ-001, Omeros Corporation, regulatory review, Study on Hold, Transplantation, United States Food and Drug Administration

FDA delays; Neurizon Therapeutics; Omeros Corporation; regulatory review; NUZ-001; narsoplimab; ALS; transplant drugs; agency staffing shortages; clinical hold