ORG – Page 8 – Talk Bio

FDA Approves Updated COVID-19 Shots from Pfizer, Moderna, Novavax with New Restrictions

2 weeks ago talkbio0Tagged COVID19 (disease), high-risk groups, LP.8.1 sublineage, Moderna, Novavax, Pfizer, restrictions, United States Food and Drug Administration, Vaccines

FDA; COVID-19 vaccine; Pfizer; Moderna; Novavax; vaccine restrictions; high-risk groups; 2025-2026 booster; LP.8.1 sublineage

Outlook Therapeutics Faces New FDA Setback for First Ophthalmic Avastin Formulation

2 weeks ago talkbio0Tagged AMD, Attitude, Avastin, bevacizumab, Blackfoot language, Clinical Trials, Eight, Glycogen storage disease type II, Lytenava, New-onset refractory status epilepticus, ophthalmic formulation, Rejection, resubmission, United States Food and Drug Administration

Outlook Therapeutics; Avastin; bevacizumab; Lytenava; wet AMD; FDA rejection; NORSE EIGHT; BLA resubmission; ophthalmic formulation; clinical trial

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

FDA Considers Noninvasive Endpoint for MASH Trials, Boosts Biotech Shares

2 weeks ago talkbio0Tagged Altimmune, Biological Markers, Clinical Trials, Inventiva, Liver diseases, Madrigal Pharmaceuticals, MASH, Noninvasive Endpoint, stocks, United States Food and Drug Administration, Viking Therapeutics

FDA; noninvasive endpoint; liver disease; MASH; clinical trials; biomarker; biotech stocks; Madrigal Pharmaceuticals; Viking Therapeutics; Inventiva; Altimmune

Prothena’s Alzheimer’s Trial Hit by High ARIA-E Rates, Resulting in ‘Non-Competitive’ Profile

2 weeks ago talkbio0Tagged Alzheimer 's disease, amyloid beta antibody, ARIA-E, ASCENT, Cerebral Edema, clinical program, non-competitive profile, Prothena, PRX012, subcutaneous administration

Prothena; PRX012; Alzheimer’s disease; ARIA-E; brain swelling; phase 1 trial; non-competitive profile; amyloid beta antibody; ASCENT clinical program; subcutaneous administration

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

Personalizing Metabolic Care with Digital Twins: Recent Developments

2 weeks ago talkbio0Tagged Administration occupational activities, Aortic Valve Insufficiency, Biological Markers, Diabetes, digital twins, Glucagon-Like Peptide 1, Health care facility, metabolic health, Obesity, Precision Medicine, real-time guidance, Reversal, Twin Health

digital twins; metabolic health; AI healthcare; personalized medicine; biomarkers; diabetes management; obesity reversal; real-time guidance; GLP-1; Twin Health

Genentech’s $700M North Carolina Plant and Telix’s FDA CRL Update

2 weeks ago talkbio0Tagged biomanufacturing, Complete Response Letter, CRL, genentech, Holly Springs, Manufacturing Facilities, Medicinal product acting as imaging agent (product), metabolic medicines, North Carolina, Obesity, Roche (company), Telix, United States Food and Drug Administration

Genentech; Roche; North Carolina; manufacturing facility; $700 million; Holly Springs; metabolic medicines; obesity treatments; biomanufacturing; Telix; FDA; Complete Response Letter (CRL); imaging agent

Exelixis to Lay Off 130 Employees, Shut Down Pennsylvania Site in Post-Pandemic Downsizing

2 weeks ago talkbio0Tagged Alameda Headquarters, cabozantinib, Exelixis, King, layoffs, Pennsylvania site closure, Post-Pandemic Downsizing, Prussia, reorganization, zanzalintinib

Exelixis; layoffs; Pennsylvania site closure; post-pandemic downsizing; biotech reorganization; Alameda headquarters; zanzalintinib; cabozantinib; King of Prussia

Exelixis Closes Pennsylvania Site, Cuts 130 Jobs in Major Restructuring

2 weeks ago talkbio0Tagged Alameda Headquarters, cancer drugs, Exelixis, King, layoffs, Pennsylvania, Prussia, restructuring, Site Closure

Exelixis; layoffs; Pennsylvania; King of Prussia; biotech; job cuts; site closure; restructuring; Alameda Headquarters; cancer drugs