Accelerated
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.
Controversy Surrounds FDA’s Fast-Track Approval of Sarepta’s Duchenne Muscular Dystrophy Gene Therapy
FDA, Sarepta Therapeutics, Duchenne Muscular Dystrophy (DMD), gene therapy, accelerated approval, controversy, clinical trials, efficacy, safety, patient advocacy, regulatory process.
FDA Fast-Tracks Day One’s Innovative Therapy for Pediatric Brain Tumors
FDA, accelerated approval, Day One, targeted treatment, pediatric brain tumors, glioma, children, cancer treatment, innovative therapy.
Brukinsa by BeiGene Secures FDA Approval for Follicular Lymphoma Amid Imbruvica Setbacks
Brukinsa (zanubrutinib), BeiGene, FDA approval, follicular lymphoma, accelerated approval, obinutuzumab (Gazyva) combination therapy, ROSEWOOD trial, overall response rate (ORR), disease progression or unacceptable toxicity, competition with CAR-T cell therapies/ bispecific antibodies