Advisory Committees – Page 2

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

6 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

7 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%

7 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

7 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

7 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

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

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

8 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

Alfasigma’s PBC Treatment Ocaliva to Face FDA Advisory Committee in September

9 months ago talkbio0Tagged Advisory Committees, Alfasigma, Biliary Cholangitis, Liver diseases, Ocaliva, PBC, Primary Biliary Cholangitis, United States Food and Drug Administration

Alfasigma, Ocaliva, PBC, FDA advisory committee, primary biliary cholangitis, liver disease treatment

FDA Advisors Back Zevra’s Rare Disease Medication Based on Clinical Intuition

9 months ago talkbio0Tagged Advisory Committees, Approved, Clinical Intuition, disease medication, Infrequent, United States Food and Drug Administration

Zevra Therapeutics, FDA advisory committee, rare disease medication, clinical intuition, potential approval

FDA Advisory Committee Approves Zevra Therapeutics’ Arimoclomol for Rare Genetic Disease Treatment

9 months ago talkbio0Tagged Advisory Committees, Arimoclomol, Drug Approval, Hereditary Diseases, Niemann-Pick Diseases, United States Food and Drug Administration

Zevra Therapeutics, Arimoclomol, FDA Advisory Committee, Niemann-Pick disease, rare genetic disease, drug approval