United States Food and Drug Administration
Lilly’s Blockbuster GLP-1 Drugs Removed from FDA Shortage List
Lilly, GLP-1, FDA, drug shortage, Mounjaro, Zepbound, tirzepatide
Novo Nordisk Withdraws FDA Submission for Wegovy’s Heart Failure Indication, Plans to Reapply Next Year
Novo Nordisk, Wegovy, FDA submission, heart failure, label expansion, regulatory delay
Stoke Therapeutics Advances Dravet Syndrome Drug to Phase III Trials After FDA Lifts Partial Clinical Hold
Stoke Therapeutics, Dravet syndrome, Phase III trials, FDA, zorevunersen, SCN1A activator, orphan drug designation, rare pediatric disease designation
FDA Approves Voranigo, the First Targeted Therapy for Grade 2 IDH-Mutant Glioma
Voranigo, FDA approval, targeted therapy, Grade 2 IDH-mutant glioma, brain tumor, Servier Pharmaceuticals, IDH1/IDH2 inhibitor
Pharma Campaign Contributions, Vaccine Hiccups, and Lykos’ Moment of Truth
Pharma campaign contributions, vaccine hiccups, Lykos Therapeutics, MDMA-assisted treatment, FDA approvals, Q2 earnings, biopharma challenges
GSK Secures Another Legal Victory in Latest Zantac Verdict
GSK, Zantac, legal victory, cancer claims, ranitidine, NDMA, FDA, pharmaceutical litigation
Actinium to Pursue Additional Clinical Trial for AML Radioactive Drug Following FDA Request
Actinium Pharmaceuticals, AML, radioactive drug, FDA, clinical trial, Iomab-B, SIERRA trial
FDA Approves First Engineered T Cell Therapy for Solid Tumors, Expands GSK’s Jemperli
FDA approval, engineered T cell therapy, solid tumors, GSK’s Jemperli, dostarlimab-gxly, afamitresgene autoleucel, Tecelra, endometrial cancer, synovial sarcoma
Actinium’s Radioconjugate Faces Setback as FDA Requests New Study
Actinium Pharmaceuticals, radioconjugate, FDA, new study, Iomab-B, regulatory affairs, biotech, cancer treatment
Eli Lilly’s Mounjaro and Zepbound Return to Stock After Extended Shortage, FDA Announces
Eli Lilly, Mounjaro, Zepbound, FDA, drug shortage, weight loss medication, diabetes medication