Rejection
FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval
FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay
Applied Therapeutics’ Rare Disease Drug Fails Another Phase 3 Trial After FDA Rejection
Applied Therapeutics; govorestat; rare disease; phase 3 failure; FDA rejection; classic galactosemia; aldose reductase inhibitor; clinical trial conduct; FDA warning letter
FDA rejection of extended dosing interval is another piece of bad news for Regenerons Eylea HD
United States Food and Drug Administration, Interval, Regeneron, dosing, Extension, Eylea HD, rejection, Age related macular degeneration, Diabetic Retinopathy
FDA Rejects Milestone Pharmaceuticals’ Etripamil Nasal Spray for PSVT
Etripamil, Cardamyst, PSVT, FDA rejection, Complete Response Letter, manufacturing issues, Milestone Pharmaceuticals
FDA Rejects Atara’s Ebvallo Due to Manufacturing Issues, Not Efficacy or Safety Concerns
Atara Therapeutics, Ebvallo, FDA rejection, manufacturing issues, post-transplant lymphoproliferative disease (PTLD), Epstein-Barr virus (EBV), T-cell immunotherapy, Pierre Fabre Laboratories.
Applied Therapeutics Undergoes Leadership Changes Amid FDA Rejection and Regulatory Challenges
Applied Therapeutics, leadership changes, FDA rejection, rare disease drug, govorestat, regulatory challenges
Applied Therapeutics Undergoes Leadership Change Amid FDA Rejection and Investor Lawsuit
Applied Therapeutics, FDA rejection, investor lawsuit, leadership change, John H. Johnson, Les Funtleyder, Shoshana Shendelman
FDA Issues Complete Response Letter for Zealand Pharma’s Glepaglutide in Short Bowel Syndrome Treatment
Zealand Pharma, Glepaglutide, GLP-2 analog, Short Bowel Syndrome (SBS), FDA rejection, Complete Response Letter
FDA Rejects Subcutaneous Version of J&J’s Lung Cancer Drug Rybrevant Due to Manufacturing Concerns
FDA rejection, J&J, Subcutaneous Rybrevant, Manufacturing issues, Lung cancer drug, Non-small cell lung cancer (NSCLC), Epidermal growth factor receptor (EGFR) mutations
FDA Rejects Applied Therapeutics’ Rare Disease Drug Govorestat, Citing Clinical Application Deficiencies
Applied Therapeutics, FDA rejection, govorestat, galactosemia, rare metabolic disease, clinical application deficiencies