Advisory Committees
FDA Raises Concerns Over Inappropriate Use of Iterum’s Antibiotic Ahead of Advisory Committee Meeting
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
FDA, checkpoint inhibitors, stomach cancer, PD-L1 expression, Oncologic Drugs Advisory Committee
Alfasigma’s PBC Treatment Ocaliva to Face FDA Advisory Committee in September
Alfasigma, Ocaliva, PBC, FDA advisory committee, primary biliary cholangitis, liver disease treatment
FDA Advisors Back Zevra’s Rare Disease Medication Based on Clinical Intuition
Zevra Therapeutics, FDA advisory committee, rare disease medication, clinical intuition, potential approval
FDA Advisory Committee Approves Zevra Therapeutics’ Arimoclomol for Rare Genetic Disease Treatment
Zevra Therapeutics, Arimoclomol, FDA Advisory Committee, Niemann-Pick disease, rare genetic disease, drug approval
FDA Advisory Panel Rejects Lykos’ MDMA Treatment for PTSD Despite Promising Results
MDMA, PTSD, FDA, Lykos Therapeutics, Psychopharmacologic Drugs Advisory Committee, psychedelic therapy
ICER Raises Concerns Over Uncertainties in Lykos MDMA Clinical Trials Ahead of FDA Advisory Committee Meeting
ICER, Lykos, MDMA, clinical trials, uncertainties, FDA, AdComm, advisory committee meeting
Lykos Therapeutics’ MDMA-Assisted Therapy for PTSD: Awaiting FDA Advisory Committee Review
Lykos Therapeutics, MDMA-assisted therapy, PTSD treatment, FDA Advisory Committee, clinical trials, drug approval process.