Health Care Related Organization – Page 2

Sanofi’s Wayrilz Receives FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia

1 week ago talkbio0Tagged Approved, Autoimmune thrombocytopenia, BTK inhibitor, Inosine Triphosphate, LUNA 3 trial, Rilzabrutinib, sanofi, United States Food and Drug Administration, Wayrilz

Wayrilz; rilzabrutinib; FDA approval; immune thrombocytopenia; ITP; BTK inhibitor; Sanofi; LUNA 3 trial

Roche and Alnylam Push Zilebesiran into Phase III Trial Despite Mixed Phase II Hypertension Data

1 week ago talkbio0Tagged Alnylam, Cardiovascular system, Hypertensive disease, KARDIA-3, outcomes, Phase 2 Clinical Trials, Phase 3 Clinical Trials, RNA Interference, Roche (company), ZENITH trial, Zilebesiran

Roche; Alnylam; zilebesiran; hypertension; RNAi therapeutics; KARDIA-3; Phase II trial; Phase III trial; cardiovascular outcomes; ZENITH trial

Genentech (Roche) Signs $420 Million Deal With OMass Therapeutics for Preclinical IBD Program

1 week ago talkbio0Tagged Drug Discovery, genentech, Inflammatory Bowel Diseases, milestone payments, OdyssION platform, OMass, Partnership, preclinical program, Roche (company), small molecule therapy

Genentech; Roche; OMass Therapeutics; inflammatory bowel disease (IBD); preclinical program; biotech partnership; OdyssION platform; small molecule therapy; drug discovery; milestone payments

AstraZeneca gears up for FDA filing after baxdrostat’s phase 3 hypertension success

1 week ago talkbio0Tagged aldosterone synthase inhibitor, AstraZeneca, baxdrostat, File (record), Hypertensive disease, regulatory approval, United States Food and Drug Administration

AstraZeneca; baxdrostat; hypertension; FDA filing; aldosterone synthase inhibitor; phase 3 trial; regulatory approval

J&J Halts Phase 2a Rheumatoid Arthritis Program for Imaavy (Nipocalimab) after Lackluster Results

2 weeks ago talkbio0Tagged Autoimmune Diseases, Clinical Research, Clinical trial failure, daisy, Imaavy, Johnson and Johnson, Nipocalimab, Phase 2a Trial, Rheumatoid Arthritis

Johnson & Johnson; Imaavy; nipocalimab; rheumatoid arthritis; Phase 2a trial; DAISY study; clinical trial failure; anti-TNFα therapy; autoimmune diseases

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

Stockpiling Frenzy Prompts Lilly to Suspend UK Mounjaro Supply

2 weeks ago talkbio0Tagged eli lilly, Mounjaro, price hike, stockpiling, supply suspension, UK, Weight-Loss Agents

Eli Lilly; Mounjaro; stockpiling; UK; supply suspension; price hike; weight loss drug; tirzepatide

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