Advisory Committees – Page 2

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

7 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

8 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

8 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%

9 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

9 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

9 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