November 2025 Brief

The FDA designates M2T-CD33 as an orphan drug, highlighting its potential as a safer, innovative treatment for acute myeloid leukemia.

The FDA has approved daratumumab and hyaluronidase for the treatment of patients with high-risk smoldering multiple myeloma.

The FDA approves generic dasatinib tablets, enhancing access and affordability for treating chronic myeloid leukemia and acute lymphoblastic leukemia.

The FDA fast-tracks AVZO-1418, a promising treatment for EGFR-mutated lung cancer, enhancing development and approval processes for patients in need.

Tinostamustine receives FDA orphan drug designation, promising new hope for glioblastoma treatment with innovative dual-action mechanism.

The FDA clears the way for a pivotal phase 3 trial of lacutamab, promising new hope for patients with cutaneous T-cell lymphomas.

The FDA approves a new diagnostic tool enhancing precision treatment for advanced endometrial carcinoma, improving patient outcomes with targeted therapies.

FDA fast-tracks alnodesertib and irinotecan for ATM-negative metastatic colorectal cancer, showing promising efficacy and safety in early trials.

The FDA approves ziftomenib for relapsed mNPM1 AML, offering new hope with promising efficacy and safety data for patients.

MB-105 receives FDA RMAT designation, advancing treatment options for relapsed T-cell lymphoma and highlighting its promising clinical potential.

The FDA approves pertuzumab-dpzb as the first interchangeable biosimilar for HER2-positive breast cancer, enhancing treatment options and accessibility.

FOG-001 receives FDA fast track designation, promising new hope for desmoid tumor patients with its innovative approach to treatment.

The FDA grants fast track designation to 4A10, a promising monoclonal antibody for treating relapsed acute lymphoblastic leukemia in children.

The FDA accepts 177Lu-edotreotide for GEP-NETs, showcasing significant survival benefits over everolimus in recent trials.

The FDA clears the EXENT System, enhancing multiple myeloma diagnosis with automated workflows and improved sensitivity for clinical laboratories.

The FDA grants fast track designation to a new noninvasive diagnostic agent for clear cell renal cell carcinoma, promising improved patient outcomes.

DPTX3186 gains FDA fast track status, promising a novel treatment for gastric cancer with potential for significant patient impact.

The FDA approves epcoritamab with rituximab and lenalidomide for relapsed follicular lymphoma, offering a new second-line treatment option.

OBI-902 receives FDA orphan drug designation for cholangiocarcinoma, promising new hope in treating this rare and aggressive cancer.

The FDA approves selumetinib for adults with neurofibromatosis type 1, offering new hope for treating inoperable plexiform neurofibromas.

The FDA has approved daratumumab and hyaluronidase plus chemotherapy for treating patients with newly diagnosed light chain amyloidosis.

The FDA has approved sevabertinib for HER2-mutant nonsquamous non–small cell lung cancer.

The FDA has granted a full approval to tarlatamab-dlle for extensive-stage small cell lung cancer.

The FDA reviews zidesamtinib for advanced ROS1+ NSCLC, promising new treatment options for patients resistant to current therapies.

The FDA approves new denosumab biosimilars, expanding treatment options for osteoporosis and cancer-related bone issues, enhancing patient access to care.

Zipalertinib shows promise as a treatment for advanced NSCLC with EGFR mutations, demonstrating significant response rates in recent trials.

The FDA approves enfortumab vedotin and pembrolizumab for muscle-invasive bladder cancer, significantly improving survival rates post-surgery.

FDA designates NBM-BMX as an orphan drug for metastatic uveal melanoma, highlighting its potential in treating this aggressive cancer.

AVZO-103 receives FDA fast track designation, offering hope for advanced urothelial cancer patients previously treated with enfortumab vedotin.

FDA approves durvalumab with FLOT chemotherapy for early-stage gastric cancer, showing promising survival rates in recent clinical trials.