Approved
Madrigal’s MASH Drug Rezdiffra Surpasses Q2 Sales Estimates
Madrigal Pharmaceuticals, Rezdiffra, MASH drug, Q2 earnings, sales estimates, FDA approval, commercial launch, NASH treatment
FDA Approves Servier’s Brain Cancer Drug, Triggering $1 Billion Payout for Agios
FDA approval, Servier, brain cancer drug, Voranigo, Agios Pharmaceuticals, IDH1 and IDH2 mutations, blood-brain barrier, cancer metabolism, royalty payments
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
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
FDA Advisors Back Zevra’s Rare Disease Medication Based on Clinical Intuition
Zevra Therapeutics, FDA advisory committee, rare disease medication, clinical intuition, potential approval
GSK Secures Broad Label Expansion for Jemperli in First-Line Endometrial Cancer
GSK, Jemperli, dostarlimab, endometrial cancer, FDA approval, chemotherapy, immuno-oncology, Keytruda, Merck
FDA Approves Tecelra, the First Engineered Cell Therapy for Solid Tumors, to Treat Synovial Sarcoma
Tecelra, Adaptimmune, FDA approval, engineered cell therapy, solid tumor, synovial sarcoma, MAGE-A4 antigen, TCR cell therapy
Adaptimmune Receives FDA Accelerated Approval for T Cell Receptor Cell Therapy in Rare Soft Tissue Cancer
Adaptimmune, FDA approval, T cell receptor cell therapy, synovial sarcoma, rare soft tissue cancer, afamitresgene autoleucel, TECELRA
FDA Approves Johnson & Johnson’s New Multiple Myeloma Therapy
FDA approval, Johnson & Johnson, multiple myeloma, CAR-T cell therapy, bispecific antibody, TALVEY, CARVYKTI, DARALEXASPRO
Sun Pharma Secures FDA Approval for Leqselvi, a JAK Inhibitor for Severe Alopecia Areata
Sun Pharma, Leqselvi, FDA Approval, Alopecia Areata, JAK Inhibitor, Pfizer, Lilly, Immunology, Dermatology