Immunologic Factor – Page 12

Vinay Prasad’s First Major Policy: Challenging Covid Vaccine ‘Dogma’ at FDA

4 months ago talkbio0Tagged Clinical Trials, COVID19 (disease), Policy, Prasad, public health medicine (field), Recommendation, Regulatory Framework, United States Food and Drug Administration, Vaccines, Vinay

Vinay Prasad; FDA; Covid-19 vaccines; policy change; clinical trials; vaccine recommendations; public health; regulatory framework

FDA Institutes Stricter, Targeted COVID Vaccine Policy, Moving Away from ‘One-Size-Fits-All’ Approach

4 months ago talkbio0Tagged Clinical Trials, COVID19 (disease), Elderly (population group), Eligibility Determination, high-risk groups, Policy, public health medicine (field), United States Food and Drug Administration, Vaccines

FDA; COVID-19; vaccine policy; vaccine eligibility; clinical trials; high-risk groups; elderly; policy change; public health

Tourmaline Bio’s Heart Drug Pacibekitug Shows Promise Against Cardiovascular Inflammation, Targets Competition with Novo, CSL

4 months ago talkbio0Tagged Cardiovascular system, heart drug, Inflammation, interleukin-6, Markers (device), Nordisk, pacibekitug, Phase 2 trial, SMPX gene, tourmaline, United States Food and Drug Administration

Tourmaline Bio; heart drug; pacibekitug; cardiovascular inflammation; inflammation markers; Novo Nordisk; CSL; Phase 2 trial; FDA; IL-6

FDA Approves Novavax COVID Vaccine After Delay, Limits Use to Smaller High-Risk Population

4 months ago talkbio0Tagged Approved, COVID19 (disease), Elderly (population group), Health conditions:-:Point in time:^Patient:-, Novavax, Nuvaxovid, protein-based vaccine, restricted population, United States Food and Drug Administration, Vaccines

Novavax; FDA approval; COVID-19 vaccine; Nuvaxovid; restricted population; protein-based vaccine; older adults; underlying health conditions

Incyte’s Zynyz Secures FDA Approval for Anal Cancer After Previous Rejection

4 months ago talkbio0Tagged Approved, Clinical Trials, Combination Drug Therapy, first-line therapy, Immunotherapy, Incyte, Inhibitor, Malignant neoplasm of anus, PDCD1 gene, POD1UM-303, Retifanlimab, United States Food and Drug Administration, Zynyz

Incyte; Zynyz; retifanlimab; FDA approval; anal cancer; PD-1 inhibitor; first-line therapy; immunotherapy; clinical trial; POD1UM-303; combination chemotherapy

AbbVie Advances Solid Tumor Program with FDA Approval of Emrelis for Lung Cancer

4 months ago talkbio0Tagged AbbVie, Accelerated, ADC, Approved, Emrelis, Malignant neoplasm of lung, MET protein, human, Non-Small Cell Lung Carcinoma, Protein Overexpression, Solid Neoplasm, Telisotuzumab, therapeutic autologous dendritic cells, United States Food and Drug Administration, vedotin-tllv

AbbVie; Emrelis; FDA Approval; ADC; solid tumor; lung cancer; non-small cell lung cancer; c-Met overexpression; telisotuzumab vedotin-tllv; accelerated approval

Merck’s Keytruda Achieves Industry-First Success in Preventing Head and Neck Cancer Recurrence: AACR 2025 Highlights

4 months ago talkbio0Tagged AACR, Cancer of Neck, Clinical Trials, Event-Free Survival, Head, KEYNOTE-689 trial, Keytruda, locally advanced head, Merck, pembrolizumab, perioperative, recurrence prevention, Squamous cell carcinoma, United States Food and Drug Administration

Keytruda; Merck; AACR 2025; head and neck cancer; resectable locally advanced head and neck squamous cell carcinoma; event-free survival; KEYNOTE-689 trial; perioperative pembrolizumab; recurrence prevention; clinical trial; FDA

GSK and iTeos End Belrestotug TIGIT Program After Disappointing Lung Cancer Results

4 months ago talkbio0Tagged belrestotug, Clinical Trials, dostarlimab, Drug Development, Galaxies, immuno-oncology, iTeos, Lung-201, Malignant neoplasm of lung, Progression-Free Survival, SmithKline Beecham, TIGIT gene

GSK; iTeos; belrestotug; TIGIT; lung cancer; dostarlimab; clinical trial; drug development; GALAXIES Lung-201; immuno-oncology; progression-free survival