Approved
Avadel Pharmaceuticals’ Narcolepsy Drug LUMRYZ Receives FDA Approval and Orphan Drug Exclusivity
Avadel Pharmaceuticals, LUMRYZ, narcolepsy, FDA approval, Orphan Drug Exclusivity, sodium oxybate, extended-release oral suspension
FDA Approves Over-the-Counter Hearing Aid Software for Apple AirPods Pro
FDA approval, over-the-counter hearing aids, Apple AirPods Pro, hearing aid software, mild to moderate hearing loss
Johnson & Johnson’s TREMFYA Receives FDA Approval for Ulcerative Colitis, Expanding Treatment Options
TREMFYA, guselkumab, FDA approval, ulcerative colitis, inflammatory bowel disease, Johnson & Johnson
F2G Secures $100M Funding for Second Attempt at FDA Approval for Novel Antifungal Drug Olorofim
F2G, antifungal drug, olorofim, FDA approval, funding, second attempt
FDA Grants Full Approval to Travere’s Filspari for IgA Nephropathy Treatment
Filspari, IgA Nephropathy, FDA Approval, Travere Therapeutics, Kidney Disease Treatment
Travere Therapeutics Secures Full FDA Approval for FILSPARI in Treating IgA Nephropathy
FILSPARI, IgA Nephropathy, FDA Approval, Kidney Disease, Travere Therapeutics
ImmunityBio Trims Workforce Despite Recent FDA Approval for Anktiva
ImmunityBio, Anktiva, FDA approval, layoffs, financial challenges, bladder cancer treatment
ImmunityBio Secures FDA Approval for ANKTIVA but Faces Financial Challenges
ImmunityBio, FDA approval, ANKTIVA, financial troubles, cancer treatment, IL-15 agonist immunotherapy
ProKidney Streamlines Phase 3 Program to Expedite U.S. Approval of Rilparencel for Chronic Kidney Disease
ProKidney, rilparencel, chronic kidney disease, CKD, cell therapy, RMAT designation, FDA approval, Phase 3 trial
ProKidney Suspends One Phase 3 CKD Cell Therapy Trial Deemed Surplus for FDA Approval
ProKidney, CKD, cell therapy, Phase 3 trial, FDA approval