October 2025 Briefs

FDA accepts T-DXd for neoadjuvant HER2-positive breast cancer treatment, promising improved outcomes and safety for high-risk patients.

FDA fast tracks ETX-636, a promising treatment for advanced breast cancer with PIK3CA mutations, aiming to improve patient outcomes.

The FDA approves lurbinectedin and atezolizumab for first-line maintenance in extensive-stage small cell lung cancer, significantly enhancing survival rates.

FDA advises against BLA submission for IO Biotech's melanoma vaccine after phase 3 trial results narrowly missed statistical significance.

FDA designates AMXT 1501 and DFMO as an orphan drug for neuroblastoma, aiming to enhance treatment outcomes for pediatric patients.

The FDA prioritizes Orca-T's review for treating hematologic malignancies, promising improved survival and reduced complications compared with traditional therapies.

FDA grants orphan drug designation to cintredekin besudotox, offering new hope for glioblastoma treatment with targeted delivery methods.

A new drug application for Dasynoc was not approved for patients with chronic myeloid leukemia and acute lymphoblastic leukemia.

The FDA has approved cemiplimab as an adjuvant treatment for high-risk cutaneous squamous cell carcinoma.

The FDA fast-tracks WTX-124, a promising therapy for advanced melanoma, aiming to improve treatment options for patients with limited choices.

FDA fast tracks ADCE-D01, a promising treatment for soft tissue sarcoma, aiming to expedite patient access and improve survival rates.

Sonrotoclax receives FDA breakthrough designation, promising new hope for patients with relapsed mantle cell lymphoma after standard treatments fail.

The FDA designates ficerafusp alfa as a breakthrough therapy for treating HPV-negative head and neck cancer, enhancing patient outcomes and options.

The FDA fast-tracks NG-350A, an innovative immunotherapy for advanced rectal cancer, aiming to enhance treatment options and patient outcomes.

FDA designates MNV-201 as an orphan drug for myelodysplastic syndrome, highlighting its innovative approach to mitochondrial dysfunction treatment.

FDA fast-tracks EO2463 immunotherapy for follicular lymphoma, promising a new treatment option backed by positive trial data and innovative technology.

The FDA reviews XS003, a new nilotinib formulation for CML, promising improved safety and convenience for patients.

FDA prioritizes review of enfortumab vedotin and pembrolizumab for muscle-invasive bladder cancer, showing promising results in reducing recurrence and mortality.

The FDA fast-tracks pamlectabart tismanitin, a promising treatment for relapsed multiple myeloma, enhancing its development and review process.

FDA approves new combinations for multiple myeloma treatment, enhancing survival rates and addressing unmet needs in patient care.

The FDA fast tracks MT-125, a promising new treatment for glioblastoma, enhancing patient care and expediting drug development.

Revumenib gains FDA approval for treating relapsed mNPM1 AML, showcasing promising efficacy and safety data from the AUGMENT-101 trial.

The FDA designates ofirnoflast as an orphan drug, highlighting its innovative approach to treating myelodysplastic syndromes and improving patient outcomes.

Zenocutuzumab gains FDA breakthrough therapy designation for advanced cholangiocarcinoma, showcasing promising trial results and potential targeted treatment options.

The FDA fast-tracks JSKN003, a promising treatment for platinum-resistant ovarian cancer, enhancing development and approval processes for this critical therapy.

The FDA designates daraxonrasib as an orphan drug for pancreatic cancer, targeting RAS mutations with promising trial results.

FDA designates ZEN-3694 as an orphan drug, offering hope for patients with NUT carcinoma with no current approved therapies.

Exosome-based therapy for glioblastoma receives FDA orphan drug designation, promising targeted treatment and improved delivery methods for cancer care.