Organism Attribute – Page 3

FDA Raises Concerns Over Inappropriate Use of Iterum’s Antibiotic Ahead of Advisory Committee Meeting

8 months ago talkbio0Tagged Advisory Committees, Antibiotic Resistance, Microbial, etzadroxil/probenecid, Iterum, sulopenem, United States Food and Drug Administration, Urinary tract infection, uUTIs

Iterum Therapeutics, FDA, antibiotic resistance, sulopenem etzadroxil/probenecid, uncomplicated urinary tract infections (uUTIs), advisory committee meeting

Women Breaking Barriers in Drug Development: Celebrating Leadership and Innovation

8 months ago talkbio0Tagged Drug Development, Drug Industry, equity, Gender, innovation, Leadership, Scanning Transmission Electron Microscopy Procedures, Woman

Women in drug development, gender equity, STEM, pharmaceutical industry, leadership, innovation

NewAmsterdam’s Obicetrapib Hits Primary Endpoint in Phase III HeFH Study, but Falls Short of Expectations

9 months ago talkbio0Tagged Cardiovascular Diseases, CETP protein, human, Familial hypercholesterolemia - heterozygous, Heterozygote, High Density Lipoprotein Cholesterol, Hypercholesterolemia, Familial, Inhibitor, LDL Cholesterol Lipoproteins, NewAmsterdam Pharma, Obicetrapib, Phase 3 Clinical Trials

NewAmsterdam Pharma, Obicetrapib, CETP Inhibitor, Phase III Trial, Heterozygous Familial Hypercholesterolemia (HeFH), LDL Cholesterol, HDL Cholesterol, Cardiovascular Disease

FDA Rejects Novo Nordisk’s Once-Weekly Insulin Icodec for Diabetes Treatment

10 months ago talkbio0Tagged Complete, Diabetes, Diabetes Mellitus, Non-Insulin-Dependent, Icodec, Insulin, Nordisk, Response process, United States Food and Drug Administration, Weekly

FDA, Novo Nordisk, Icodec, Weekly Insulin, Diabetes Treatment, Type 1 Diabetes, Type 2 Diabetes, Complete Response Letter

FDA Rejects Rocket Pharmaceuticals’ Gene Therapy for Ultra-Rare Immune Disease, Requests Additional Manufacturing Information

10 months ago talkbio0Tagged Complete, control act - information, deficiency-I, gene therapy, LAD-I, leukocyte cell-cell adhesion, Manufacture, Response process, Rocket, United States Food and Drug Administration

FDA, Rocket Pharmaceuticals, Gene Therapy, Leukocyte Adhesion Deficiency-I (LAD-I), Manufacturing Information, Complete Response Letter

GSK’s RSV Vaccine Wins Expected Expansion into At-Risk Adults Aged 50-59

11 months ago talkbio0Tagged Adult, Age, Approved, Arexvy, Asthma, Chronic Obstructive Airway Disease, Diabetes, Heart failure, Increased, medical conditions, Respiratory syncytial virus, Respiratory Tract Diseases, Risk, SmithKline Beecham, United States Food and Drug Administration, Vaccines

GSK, RSV vaccine, Arexvy, FDA approval, adults aged 50-59, increased risk, respiratory syncytial virus, lower respiratory tract disease, medical conditions, chronic obstructive pulmonary disease, asthma, heart failure, diabetes.