Advisory Committees – Page 3

FDA Advisory Committee Rejects Lexicon’s Zynquista for Type 1 Diabetes and Chronic Kidney Disease

10 months ago talkbio0Tagged Advisory Committees, Chronic Kidney Diseases, Drug Approval, lexicon, United States Food and Drug Administration, Zynquista

FDA, Lexicon Pharmaceuticals, Zynquista, sotagliflozin, type 1 diabetes, chronic kidney disease, FDA advisory committee, drug approval

FDA Advisory Committee Votes Against Zynquista for Type 1 Diabetes and Chronic Kidney Disease, Despite Support for Subgroup Benefits

10 months ago talkbio0Tagged (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol, Advisory Committees, Chronic Kidney Diseases, Diabetes Mellitus, Insulin-Dependent, Glycemic Control, Inhibitor, lexicon, SGLT1/SGLT2, United States Food and Drug Administration, Zynquista

FDA Advisory Committee, Zynquista (sotagliflozin), Type 1 Diabetes (T1D), Chronic Kidney Disease (CKD), Glycemic Control, SGLT1/SGLT2 Inhibitor, Lexicon Pharmaceuticals

Lexicon’s Diabetes Drug Zynquista Faces FDA Scrutiny Again Ahead of Advisory Committee Meeting

10 months ago talkbio0Tagged Advisory Committees, Diabetes, lexicon, regulatory, United States Food and Drug Administration, Zynquista

Lexicon Pharmaceuticals, Zynquista, FDA, diabetes drug, advisory committee, regulatory challenges

FDA Advisory Committee Supports Stealth BioTherapeutics’ Elamipretide for Barth Syndrome Despite Data Concerns

10 months ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Advisory Committees, Elamipretide, Stealth BioTherapeutics, ultra-rare disease, United States Food and Drug Administration, unmet

Stealth BioTherapeutics, elamipretide, Barth syndrome, FDA advisory committee, ultra-rare disease, unmet medical need

FDA Raises Concerns Over Stealth BioTherapeutics’ Ultra-Rare Disease Drug Ahead of Advisory Committee Meeting

11 months ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Advisory Committees, concerns, Drug Approval, Effectiveness, Elamipretide, Stealth BioTherapeutics, ultra-rare disease, United States Food and Drug Administration

FDA, Stealth BioTherapeutics, elamipretide, Barth syndrome, ultra-rare disease, advisory committee meeting, drug approval, efficacy concerns

FDA Cancels Advisory Committee Meeting for Applied Therapeutics’ Govorestat, Stock Surges 65%

11 months ago talkbio0Tagged Advisory Committees, Galactosemias, Govorestat, surge, United States Food and Drug Administration

Applied Therapeutics, FDA, Advisory Committee, Govorestat, Galactosemia, Stock Surge

FDA Advisory Committee Votes Against Ocaliva for Primary Biliary Cholangitis Due to Safety Concerns

11 months ago talkbio0Tagged Advisory Committees, Biliary Cholangitis, concerns, Liver diseases, Ocaliva, Safety, United States Food and Drug Administration, Voting

Ocaliva, FDA, Primary Biliary Cholangitis, Liver Disease, Safety Concerns, Advisory Committee Vote

FDA Flags Concerns Over Intercept’s Ocaliva Approval in Advisory Committee Briefing

11 months ago talkbio0Tagged Advisory Committees, Biliary Cholangitis, Intercept Substance, Liver diseases, Ocaliva, United States Food and Drug Administration

Ocaliva, Intercept Pharmaceuticals, FDA, Advisory Committee, Primary Biliary Cholangitis, Liver Disease

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

12 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

FDA to Reassess Checkpoint Inhibitors for Stomach Cancer Based on PD-L1 Expression

12 months ago talkbio0Tagged Advisory Committees, checkpoint inhibitors, Gene Expression, Oncologic, PD-L1, United States Food and Drug Administration

FDA, checkpoint inhibitors, stomach cancer, PD-L1 expression, Oncologic Drugs Advisory Committee