Accelerated
Sangamo Therapeutics Fast-Tracks Fabry Gene Therapy with FDA Accelerated Approval Pathway
Sangamo Therapeutics, Fabry disease, gene therapy, isaralgagene civaparvovec, FDA, accelerated approval pathway, ST-920, STAAR study
Otsuka Seeks Accelerated Approval for Sibeprenlimab in IgA Nephropathy Following Positive Phase III Interim Results
Otsuka, sibeprenlimab, IgA nephropathy, Phase III trial, accelerated approval, FDA, kidney disease, autoimmune disease, APRIL antibody.
Gilead Withdraws Trodelvy for Bladder Cancer in US After Confirmatory Trial Failure
Gilead Sciences, Trodelvy, bladder cancer, urothelial carcinoma, FDA, accelerated approval, drug withdrawal
Agenus Faces Uphill Battle After FDA Rejects Accelerated Approval for Cancer Drug Combo
Agenus, FDA, Cancer Drug Combo, BOT/BAL, Colorectal Cancer, Accelerated Approval, Stock Selloff
FDA Discourages Accelerated Approval for Agenus’ Colorectal Cancer Combination, Prompting Partnership Search
Agenus, FDA, Accelerated Approval, Colorectal Cancer, Botensilimab, Balstilimab, Immunotherapy Combination, Phase III Trial, Partnership
Wave Life Sciences Achieves Breakthrough in Huntington’s Disease Treatment with WVE-003, Eyes Accelerated Approval
Wave Life Sciences, Huntington’s disease, WVE-003, Phase Ib/IIa study, accelerated approval, mutant huntingtin protein, allele-selective silencing, RNA medicine
Bristol Myers’ KRAS Confirmatory Data Avoid Amgen’s Flaws but Leave FDA Prospect Unclear
Bristol Myers Squibb, KRAS confirmatory data, Amgen, FDA, accelerated approval pathway, oncology therapies, clinical benefits, confirmatory trials
BMS Details Confirmatory Trial Win for KRAS Inhibitor Krazati
Bristol Myers Squibb, Krazati, KRAS inhibitor, confirmatory trial, non-small cell lung cancer (NSCLC), progression-free survival (PFS), chemotherapy, accelerated approval, FDA
Regulatory Tracker: Lilly’s Retevmo Secures Pediatric Cancer FDA Nod ###
Retevmo, Eli Lilly, FDA approval, pediatric cancer, RET-altered, thyroid cancer, solid tumors, accelerated approval, LIBRETTO-121 trial, selpercatinib
FDA Revokes Accelerated Approval of Helsinn’s Cancer Drug at Company’s Request
FDA, Helsinn, accelerated approval, cancer drug, company request, drug withdrawal, regulatory decision, clinical trials, patient safety.