United States Food and Drug Administration – Page 19

United Therapeutics’ Tyvaso Succeeds in Phase 3 IPF Trial, Marking Major Advance in Lung Disease Treatment

4 months ago talkbio0Tagged Clinical Trials, Forced Vital Capacity, Idiopathic Pulmonary Fibrosis, IPF, Lung diseases, nebulized body site, Pulmonary Fibrosis, TETON-2, Tyvaso, United States Food and Drug Administration, United Therapeutics, Vital capacity test

Tyvaso; United Therapeutics; idiopathic pulmonary fibrosis; IPF; Phase 3 trial; TETON-2; lung disease; forced vital capacity; FVC; clinical trial; FDA; nebulized treprostinil

Ionis Posts Strong Results for Tryngolza in Severe Blood Fat Disease

4 months ago talkbio0Tagged Approved, cardiovascular risk reduction, drug launch, Familial chylomicronemia syndrome, Hypertriglyceridemia, Ionis Pharmaceuticals, Olezarsen, Phase III Essence study, Triglycerides, TRYNGOLZA, United States Food and Drug Administration

Ionis Pharmaceuticals; Tryngolza; olezarsen; hypertriglyceridemia; triglycerides; Phase III Essence study; FDA approval; familial chylomicronemia syndrome; cardiovascular risk reduction; drug launch

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

4 months 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

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

4 months 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

4 months 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

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

4 months 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

4 months 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

4 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 Considers Noninvasive Endpoint for MASH Trials, Boosts Biotech Shares

4 months 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

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

4 months 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