December 2025 – Page 5

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

1 month 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

Specific Biologics Appoints Dr. Richard Glickman to Board of Directors

1 month ago talkbio0Tagged Biological Factors, Biotechnology, board of directors, Genome Editing, Glickman

Specific Biologics; Richard Glickman; Board of Directors; biotechnology; genome editing

Medivis First to Receive FDA Clearance for Augmented Reality Navigation in Neurosurgery

1 month ago talkbio0Tagged AR navigation, augmented, Clearance, Cranial Navigation platform, cranial neurosurgery, External Ventricular Drain, ICU bedside procedures, intraoperative guidance, Medivis, neurosurgery innovation, Spine Navigation, surgical intelligence, United States Food and Drug Administration

Medivis; FDA 510(k) clearance; augmented reality; AR navigation; cranial neurosurgery; intraoperative guidance; cranial navigation platform; external ventricular drain; ICU bedside procedures; surgical intelligence; spine navigation; neurosurgery innovation

Sanofi Licenses ADEL’s Tau-Targeting Alzheimer’s Drug for $1.04 Billion Deal Including $80M Upfront

1 month ago talkbio0Tagged ADEL, Alzheimer 's, sanofi, tau-targeting

Sanofi; ADEL; Alzheimer’s; tau-targeting; licensing deal; biotech

FDA Advances Real-World Data Use and Early-Phase Trial Reforms to Accelerate Drug Approvals

1 month ago talkbio0Tagged Drug Approval, early-phase trials, real-world data, real-world evidence, Real-world Evidence, RWE, Transplant Registry Unified Management Program, Trump, United States Food and Drug Administration

FDA; real-world data; real-world evidence; RWE; early-phase trials; drug approval; Marty Makary; Trump

The 5 Most Painful Clinical Trial Failures of 2025

1 month 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

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

1 month 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

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

1 month 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

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

1 month 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

Noom Launches Proactive Health Microdose GLP-1 Program for Lower BMI Group Beyond Obesity Labels

1 month ago talkbio0Tagged Body mass index procedure, Glucagon-Like Peptide 1, Longevity, microdosing, Noom, Preventive Health Services, Proactive Health

Noom; GLP-1 microdosing; Proactive Health; BMI 21+; longevity; preventive health