January 2026 FDA Briefs

Sevabertinib receives breakthrough therapy designation for treating advanced HER2-mutant non-small cell lung cancer, promising new hope for patients.

A new drug application for rusfertide aims to transform polycythemia vera treatment, reducing phlebotomy needs and improving patient outcomes.

CK0804, a novel Treg therapy, gains FDA orphan drug status for myelofibrosis, promising new hope for patients with limited treatment options.

Atossa Therapeutics advances Z-endoxifen for metastatic breast cancer, showing promise in clinical trials and receiving FDA approval to proceed with studies.

CPI-008 receives orphan drug designation, enhancing surgical imaging for pancreatic cancer and promising improved outcomes in challenging surgeries.

ETX-19477 receives FDA fast track designation, promising accelerated development for treating BRCA-mutated, platinum-resistant ovarian cancer patients.

The FDA clears KLN-1010, a groundbreaking in vivo gene therapy for relapsed multiple myeloma, enhancing CAR-T treatment accessibility and efficacy.

The FDA designates zoldonrasib as a breakthrough therapy for KRAS G12D-mutated lung cancer, highlighting its promising efficacy and safety profile.

The FDA designates ARB1002 as an orphan drug, highlighting its potential as a novel treatment for pancreatic cancer amid limited options.

FDA meeting guides Plus Therapeutics in advancing rhenium Re 186 obisbemeda for leptomeningeal metastases, paving the way for pivotal trials.

A novel oral fascin inhibitor, NP-G2-044, shows promise in treating pancreatic cancer, earning FDA orphan drug designation for innovative therapies.

The FDA denies accelerated approval for tabelecleucel, highlighting ongoing challenges in treating EBV-positive posttransplant lymphoproliferative disease.

BioNTech's gotistobart receives FDA orphan drug designation, showing promise in improving survival for patients with squamous non–small cell lung cancer.

The FDA designates ICT01 as a breakthrough therapy for unfit AML patients, showcasing promising efficacy in early clinical trials.

The FDA reviews ropeginterferon alfa-2b-njft for essential thrombocythemia, showing promising efficacy in clinical trials for patients.

The FDA reviews gedatolisib, a promising treatment for advanced breast cancer, aiming to enhance patient outcomes with innovative combination therapies.

Sofetabart mipitecan receives FDA breakthrough therapy designation, showing promising efficacy in treating platinum-resistant ovarian cancer.

The FDA designates soficabtagene geleucel as a breakthrough therapy, highlighting its potential in treating relapsed T cell leukemia and lymphoma.

FDA fast-tracks BNT113, an mRNA immunotherapy, for treating HPV16+ head and neck cancer, enhancing immune responses alongside pembrolizumab.

The FDA released draft guidance on minimal residual disease and complete response as trial end points to accelerate multiple myeloma drug approvals.