authorization – Talk Bio

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

2 months ago talkbio0Tagged Artificial Intelligence, 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 may not renew Pfizer’s pediatric COVID-19 shot authorization, creating uncertainty for fall child vaccinations

2 months ago talkbio0Tagged Advice, authorization, Centers for Disease Control and Prevention (U.S.), Child, Comparison, COVID19 (disease), EUA, Eua (gastropod), Moderna, Pediatric brand name, Pfizer-BioNTech, Regulatory Framework, renewal, United States Food and Drug Administration, Vaccination, Vaccines

FDA; Pfizer-BioNTech; pediatric COVID-19 vaccine; EUA renewal; authorization not renewed; child vaccinations; fall 2025; regulatory framework; Moderna comparison; CDC guidance

Lark Health Launches LarkVantage: AI-Powered Platform to Manage GLP-1 Costs

4 months ago talkbio0Tagged Administration occupational activities, Artificial Intelligence, authorization, cost management, Gibbs, Glucagon-Like Peptide 1, Health care facility, Health Planning, Lark Health, LarkVantage, Pharmacy Benefit Manager, utilization qualifier, Weight maintenance regimen

Lark Health; LarkVantage; GLP-1 cost management; AI healthcare; prior authorization; utilization management; PBM; health plans; weight management; Matthew Gibbs

Leqembi wins EU authorization for some Alzheimer’s patients, giving Biogen, Eisai a boost over Lilly

6 months ago talkbio0Tagged Alzheimer, Apolipoprotein E4, ARIA, authorization, Biogen, Eisai, Eli Lilly, EU, High, Kisunla, Leqembi, Restricted

Leqembi, EU, Eisai, Eli Lilly, ARIA, Biogen, authorization, Alzheimer, Kisunla, Restricted, Apolipoprotein E4, High

European Commission Revokes Marketing Authorization for Ocaliva, a Liver Disease Drug, Amid Regulatory Dispute

11 months ago talkbio0Tagged Advanz Pharma, authorization, Commission, European (ethnic group), Liver diseases, Ocaliva, PBC, Primary Biliary Cholangitis

Ocaliva, European Commission, Marketing Authorization, Liver Disease, Primary Biliary Cholangitis (PBC), Advanz Pharma

FDA Authorizes LumiThera’s Valeda Light Delivery System for Dry AMD Treatment

12 months ago talkbio0Tagged authorization, Desiccation, Glycogen storage disease type II, LumiThera, photobiomodulation, United States Food and Drug Administration, Valeda Light Delivery System

FDA authorization, Valeda Light Delivery System, dry AMD treatment, photobiomodulation, LumiThera

European Court Suspends EC’s Decision to Revoke Ocaliva’s Marketing Authorization

1 year ago talkbio0Tagged Advanz Pharma, authorization, Biliary Cholangitis, court, Decision, EC, European (ethnic group), Ocaliva, Primary Biliary Cholangitis

Ocaliva, European Court, EC decision, marketing authorization, primary biliary cholangitis, PBC, Advanz Pharma

FDA Authorizes Novavax’s Updated COVID-19 Vaccine for Emergency Use

1 year ago talkbio0Tagged authorization, COVID19 (disease), Emergency Situation, JN.1, Novavax, protein-based vaccine, United States Food and Drug Administration, Vaccines, Variant

Novavax COVID-19 Vaccine, FDA Authorization, Emergency Use, Protein-Based Vaccine, JN.1 Variant

Novavax’s Updated COVID-19 Vaccine Receives FDA Emergency Use Authorization

1 year ago talkbio0Tagged authorization, COVID19 (disease), Emergency Situation, JN.1, Novavax, protein-based vaccine, United States Food and Drug Administration, Vaccines, Variant

Novavax, COVID-19 vaccine, FDA, Emergency Use Authorization, protein-based vaccine, JN.1 variant

FDA Limits Use of Invivyd’s COVID-19 Prophylactic as New Variants Dominate

1 year ago talkbio0Tagged authorization, COVID19 (disease), Emergency Situation, Immunocompromised Host, Invivyd, Pemgarda, United States Food and Drug Administration, Variant

Invivyd, COVID-19, Pemgarda, Emergency Use Authorization, FDA, Immunocompromised, Variants