FDA Alerts

An FDA advisory committee voted in favor of GRAIL’s Galleri multi-cancer early detection test for adults aged 50 years and older, supporting its safety, effectiveness, and overall benefit-risk profile as the agency continues review of its...

The FDA granted Fast Track designation to LYT-200 plus a hypomethylating agent for relapsed or refractory high-risk myelodysplastic syndromes following early-phase findings demonstrating clinical activity and supporting advancement of the...

The FDA approved a supplemental new drug application updating the taletrectinib label with longer-term TRUST-I data demonstrating sustained response durability in TKI-naïve advanced ROS1-positive non-small cell lung cancer, with no new safety...

The FDA updated the prescribing information for tarlatamab to substantially shorten monitoring following the first 2 doses in patients with extensive-stage small cell lung cancer, potentially reducing treatment burden and facilitating...

The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 that efficacy findings from the phase 2 IGNYTE trial of RP1 (vusolimogene oderparepvec) plus nivolumab are clinically meaningful, supporting the investigational...

The FDA granted Priority Review to subcutaneous amivantamab and hyaluronidase for previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma, supported by results from the phase 1b/2 OrigAMI-4 trial.

The FDA accepted for review a New Drug Application for daraxonrasib in adults with previously treated metastatic pancreatic ductal adenocarcinoma based on the phase 3 RASolute 302 trial, which demonstrated improvements in overall survival,...

The FDA accepted the new drug application for mezigdomide plus carfilzomib and dexamethasone for relapsed or refractory multiple myeloma based on phase 3 SUCCESSOR-2 results demonstrating a significant progression-free survival benefit...

The FDA accepted the new drug application for varegacestat for adults with progressing desmoid tumors following positive results from the phase 3 RINGSIDE trial, supporting the investigational oral gamma secretase inhibitor as a potential new...

The FDA issued a safety alert regarding tazemetostat, citing an increased risk of hematologic second primary malignancies observed in the ongoing SYMPHONY-1 trial.