Qualitative Concept – Page 3

Zenas BioPharma Secures $300M Royalty Deal for Obexelimab FDA Approvals

1 week ago talkbio0Tagged Approved, Autoimmune Diseases, IgG4-Related Disease, Lupus Erythematosus, Systemic, Obexelimab, Phase 3 INDIGO trial, Royalty, Royalty Pharma, United States Food and Drug Administration, Zenas BioPharma

Zenas BioPharma; Royalty Pharma; Obexelimab; autoimmune diseases; IgG4-Related Disease; Systemic Lupus Erythematosus; FDA approval; royalty agreement; Phase 3 INDIGO trial; funding

Teva Launches First Generic GLP-1 Weight-Loss Drug in the US

2 weeks ago talkbio0Tagged Approved, Generic Drugs, Glucagon-Like Peptide 1, liraglutide, Obesity, Saxenda, Teva, United States, United States Food and Drug Administration, Weight Loss

Teva; GLP-1; generic; weight loss; liraglutide; FDA approval; Saxenda; obesity treatment; United States

ESC25: GE HealthCare Showcases AI Cardiology Innovations for Earlier and More Accurate Diagnoses

2 weeks ago talkbio0Tagged Aortic Valve Insufficiency, authorization, Cardiac imaging, Cardiology discipline, CardIQ, Diagnostic Accuracy, Electrophysiology (science), ESC25, GE HealthCare, Molecular Imaging, Revolution Vibe CT, United States Food and Drug Administration, ViewPoint EchoPilot, workflow automation

GE HealthCare; ESC25; AI cardiology; diagnostic accuracy; ViewPoint EchoPilot; CardIQ Suite; Revolution Vibe CT; molecular imaging; workflow automation; electrophysiology; cardiac imaging; FDA authorization

Vinay Prasad Explains FDA’s Revocation of Pfizer’s Covid Vaccine EUA for Children

2 weeks ago talkbio0Tagged Child, COVID19 (disease), Emergency Situation, Emergency Use Authorization, EUA, Pfizer, Policy, Prasad, risk-benefit analysis, United States Food and Drug Administration, Vaccines

FDA; Pfizer; COVID-19 vaccine; emergency use authorization (EUA); children; Vinay Prasad; vaccine policy; risk-benefit analysis

Wugen Nabs $115M for Pivotal Study of Allogeneic CAR-T

2 weeks ago talkbio0Tagged Allogeneic, CAR-T, Clinical Trials, fratricide-resistant, T-cell malignancies, Wugen

Wugen; CAR-T; allogeneic; off-the-shelf therapy; fratricide-resistant; funding; pivotal trial; T-cell malignancies

Sanofi Contributes to Report Emphasizing Importance of Sustainably Paid Community Health Workers

2 weeks ago talkbio0Tagged Advocacy, CHW Access Act, Community Health Workers, digital infrastructure, Health Equity, National Association of, Policy, sanofi, sustainability

Sanofi; community health workers; sustainability; health equity; National Association of Community Health Workers; policy advocacy; digital infrastructure; CHW Access Act

Vinay Prasad Returns to the FDA With Fewer Titles and a Lower Profile

2 weeks ago talkbio0Tagged Center for Biologics Evaluation and Research, gene therapy, Lower Profile, Prasad, research, Return to (contextual qualifier) (qualifier value), Titles, United States Food and Drug Administration, vaccine regulation, Vinay

Vinay Prasad; FDA; return; Center for Biologics Evaluation and Research (CBER); fewer titles; lower profile; gene therapy; vaccine regulation

Hundreds of HHS Workers Accuse RFK Jr. of Destroying Public Health Trust After CDC Attack

2 weeks ago talkbio0Tagged CDC, Centers for Disease Control and Prevention (U.S.), federal workers, harassment, Health, HHS, Misinformation, Public Health Trust, RFK Jr., vaccine skepticism, Violence

RFK Jr.; Health and Human Services (HHS); CDC attack; public health trust; misinformation; vaccine skepticism; harassment; violence against federal workers

Lilly to Seek Global Approval for GLP-1 Pill After Obesity and Diabetes Trial Success

2 weeks ago talkbio0Tagged Approved, Clinical Trials, Contraceptives, Oral, Diabetes Mellitus, Non-Insulin-Dependent, Eli, Eli Lilly, Glucagon-Like Peptide 1, Obesity, orforglipron, United States Food and Drug Administration, Weight Loss

Eli Lilly; GLP-1 pill; orforglipron; obesity; type 2 diabetes; FDA approval; weight loss; clinical trial

Akeso, Summit’s PD-1xVEGF Drug Ivonescimab Shows Strong Progression-Free Survival Benefit in Global Lung Cancer Trial

2 weeks ago talkbio0Tagged Akeso, Antibodies, Bispecific, Approved, Ivonescimab, Non-Small Cell Lung Carcinoma, Overall Survival, PD-1xVEGF, Phase 3 trial, Progression-Free Survival, summit, United States Food and Drug Administration

Akeso; Summit Therapeutics; ivonescimab; PD-1xVEGF; bispecific antibody; non-small cell lung cancer; progression-free survival; Phase 3 trial; overall survival; FDA approval