Disease or Syndrome

FDA Commissioner Makary Addresses COVID-19 Vaccine Safety Concerns Amid Internal Debates and Investigations

23 hours ago talkbio0Tagged Cautionary Warning, COVID19 (disease), Marty Makary, mRNA Vaccines, Myocarditis, RFK gene, Safety, United States Food and Drug Administration, vaccine deaths, Vaccines

Marty Makary; FDA; COVID-19 vaccine; myocarditis; vaccine deaths; safety warnings; RFK Jr.; mRNA vaccines

Harbour BioMed inks $90M upfront, $1B+ antibody alliance with Bristol Myers Squibb

1 day ago talkbio0Tagged biobucks, Burning Mouth Syndrome, China, Clinical Trials, global strategic collaboration, Harbour BioMed, Harbour Mice ® technology, Immunology, License Agreement, milestones, multi-specific antibodies, Myers Squibb, Neoplasms

Harbour BioMed; Bristol Myers Squibb; BMS; multi-specific antibodies; $90 million upfront; $1.035 billion milestones; global strategic collaboration; license agreement; Harbour Mice technology; immunology; oncology; biobucks deal; China early clinical trials

Nektar Digs Into Mid-Stage Data To Establish Alopecia Efficacy of Rezpeg

1 day ago talkbio0Tagged Alopecia, Autoimmune Diseases, Effectiveness, eli lilly, IL-2 pathway, mid-stage trial, Nektar Therapeutics, Phase 3 planning, REZOLVE-AA, Rezpeg, Rezpegaldesleukin, SALT score * *, Signal

Nektar Therapeutics; rezpegaldesleukin; Rezpeg; REZOLVE-AA; Phase 2b; alopecia areata; hair loss; SALT score; mid-stage trial; efficacy signal; Eli Lilly; IL-2 pathway; autoimmune disease; Phase 3 planning

GSK wins FDA approval for ultra-long-acting asthma drug Exdensur (depemokimab)

1 day ago talkbio0Tagged Approved, Asthma, biology (field), Depemokimab, dosing, eosinophilic, Exdensur, IL-5 Inhibitor, Phenotype, Severe (severity modifier), SmithKline Beecham, twice-yearly, type 2 inflammation, ultra-long acting, United States Food and Drug Administration

GSK; Exdensur; depemokimab; FDA approval; severe asthma; ultra-long-acting biologic; twice-yearly dosing; type 2 inflammation; eosinophilic phenotype; IL-5 inhibitor

Ambros Therapeutics launches with $125M to develop non-opioid chronic pain drug neridronate

1 day ago talkbio0Tagged * * Vivek Ramaswamy * *, 6-amino-1-hydroxyhexane-1,1-diphosphonate, Ambros Therapeutics, Analgesics, Non-Narcotic, Chronic pain, Complex Regional Pain Syndromes, CRPS-1, Diphosphonates, Series A

Ambros Therapeutics; $125 million Series A; chronic pain; complex regional pain syndrome type 1; CRPS-1; neridronate; non-opioid analgesic; bisphosphonate; Vivek Ramaswamy; biotech financing

RTW-backed startup Yarrow Bioscience signs autoimmune antibody deal with China’s GenSci

1 day ago talkbio0Tagged anti-TSHR antibody, Antibodies, Autoimmune, Changchun GeneScience Pharmaceutical, China, GenSci, GS-098, Investments, RTW, strategic partnership, Thyroid associated opthalmopathies, Yarrow Bioscience, YB-101

RTW Investments; Yarrow Bioscience; GenSci; Changchun GeneScience Pharmaceutical; autoimmune; antibody; GS-098; YB-101; anti-TSHR antibody; thyroid eye disease; China; ex-China rights; strategic partnership; licensing deal

J&J’s Tecvayli and Darzalex Combo Wins FDA’s Proactive National Priority Voucher for Relapsed/Refractory Multiple Myeloma

2 days ago talkbio0Tagged Asymmetric Septal Hypertrophy, CNPV, Darzalex, J&J, Multiple Myeloma, National Priority Voucher, TECVAYLI, United States Food and Drug Administration

J&J; FDA; National Priority Voucher; Tecvayli; Darzalex; Multiple Myeloma; CNPV; ASH 2025

The 5 Most Painful Clinical Trial Failures of 2025

2 days ago talkbio0Tagged 2025, approvals, Clinical Trial Failures, gene therapy, Mississippi (geographic location), Muscular Dystrophy, Duchenne, United States Food and Drug Administration

clinical trial failures; 2025; biotech; gene therapy; MS; DMD; FDA approvals

Sanofi returns to Dren Bio for another B‑cell depletion therapy with $100M upfront

2 days ago talkbio0Tagged Antibodies, Bispecific, Autoimmune Diseases, B-Lymphocytes, Depletion, Dren Bio, Immunology, Myeloid cell engager, sanofi, strategic collaboration, upfront

Sanofi; Dren Bio; B-cell depletion; autoimmune diseases; strategic collaboration; bispecific antibody; myeloid cell engager; immunology; $100M upfront; licensing deal

Kyverna to seek FDA engagement after positive autoimmune CAR-T data in stiff person syndrome

2 days ago talkbio0Tagged Autoimmune Diseases, CAR-T, Cell Therapy, KYV-101, Kyverna, Regulatory Path, SPS, Stiff-Person Syndrome, United States Food and Drug Administration

Kyverna; KYV-101; CAR-T; autoimmune disease; stiff person syndrome; SPS; FDA; regulatory path; cell therapy