United States Food and Drug Administration – Page 9

Paul Offit, RFK Jr. Critic, Removed from Key FDA Vaccine Panel

2 months ago talkbio0Tagged Advisory Committees, CHARGE Syndrome, Paul Offit, Policy, removal technique, RFK Jr., United States Food and Drug Administration, vaccine panel, Vaccines, VRBPAC

Paul Offit; FDA; vaccine panel; RFK Jr.; removal; vaccine policy; VRBPAC; advisory committee; HHS

Ionis Builds Case for Wider Tryngolza Use in Severe Lipid Disorders Following Positive Phase 3 Results

2 months ago talkbio0Tagged drug indication, expansion, Familial chylomicronemia syndrome, Hypertriglyceridemia, Ionis Pharmaceuticals, Lipid Metabolism Disorders, Olezarsen, Pancreatitis, Acute, Severe (severity modifier), TRYNGOLZA, United States Food and Drug Administration

Ionis Pharmaceuticals; Tryngolza; olezarsen; severe hypertriglyceridemia; lipid disorder; Phase 3 trial; familial chylomicronemia syndrome; acute pancreatitis; FDA; drug indication expansion

Eisai Secures FDA Approval for Leqembi Autoinjector for Maintenance Dosing in Alzheimer’s Patients

2 months ago talkbio0Tagged Alzheimer 's disease, Approved, at-home, AutoInjector, Biogen, dosing, Eisai, Lecanemab, Leqembi, Maintenance, Subcutaneous Injections, United States Food and Drug Administration

Eisai; Leqembi; lecanemab; FDA approval; autoinjector; subcutaneous injection; maintenance dosing; Alzheimer’s disease; at-home treatment; Biogen

Cytokinetics Stock Soars After Positive Phase 3 Data as FDA Approval Decision for Aficamten Nears

2 months ago talkbio0Tagged Aficamten, Approved, Cytokinetics, Hypertrophic obstructive cardiomyopathy, PDUFA, Performance, REMS, United States Food and Drug Administration

Cytokinetics; Aficamten; FDA approval; Phase 3 trial; obstructive hypertrophic cardiomyopathy (oHCM); PDUFA date; REMS; stock performance

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

2 months 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

Vinay Prasad Details New Approach to COVID-19 Vaccine Approvals in Recent FDA Memos

2 months ago talkbio0Tagged Child, COVID19 (disease), Evidence, Prasad, regulatory decisions, risk-benefit analysis, Spikevax, United States Food and Drug Administration, vaccine approval, Vaccine Safety, Vaccines, Vinay

Vinay Prasad; COVID-19 vaccine; FDA; vaccine approval; children; Spikevax; regulatory decisions; vaccine safety; evidence; risk-benefit analysis

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

2 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

2 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

2 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

2 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