July 2025 Brief

The FDA designates the TOBY Test as a breakthrough device, revolutionizing bladder cancer detection with a non-invasive, AI-driven urine test.

The SonoClear System revolutionizes neurosurgery with FDA breakthrough designation, enhancing ultrasound imaging for safer tumor resections in glioma surgeries.

Linvoseltamab represents a promising new approach to treating multiple myeloma through immune-based therapy.

FDA accelerates approval of sunvozertinib for advanced NSCLC with EGFR mutations, offering new hope for patients after chemotherapy.

The FDA approves a rapid test for identifying patients with NSCLC eligible for sunvozertinib, enhancing timely, precision oncology care.

The FDA approves SIR-Spheres Y-90 microspheres for treating unresectable hepatocellular carcinoma, showcasing impressive efficacy and safety in clinical trials.

FDA designates FF-10832 as an orphan drug for biliary tract cancer, promising enhanced treatment options for this aggressive malignancy.

FDA designates MB-101 CAR T-cell therapy for glioblastoma, highlighting its potential in treating aggressive brain tumors with innovative combination strategies.

FDA's new draft guidance enhances drug development for myelodysplastic syndromes, focusing on trial design, patient selection, and safety reporting.

Adcentrx Therapeutics advances gastric cancer treatment with FDA orphan drug designation for ADRX-0405, a promising antibody-drug conjugate in clinical trials.

Celltrion USA launches 2 denosumab biosimilars, Stoboclo and Osenvelt, enhancing treatment options for osteoporosis and cancer-related skeletal issues.

The FDA reviews an all-oral treatment for newly diagnosed AML, combining decitabine, cedazuridine, and venetoclax, showing promising trial results.

A new FDA application for relacorilant shows promising survival benefits in treating platinum-resistant ovarian cancer, enhancing standard chemotherapy outcomes.

Pierre Fabre leads global development of tab-cel, an innovative therapy for EBV+ PTLD, with ongoing trials and potential FDA approval on the horizon.

The FDA designates SH-110 as an orphan drug, offering a safer oral treatment option for glioma patients with swallowing difficulties.

The FDA clears GL-IL2-138, a groundbreaking oral drug modulating natural IL-2, set to revolutionize treatment in oncology.

Zenith Epigenetics' ZEN-3694 gains FDA fast track designation, offering hope for patients with aggressive NUT carcinoma through innovative treatment combinations.

The FDA prioritizes TAR-200 for treating high-risk bladder cancer, showcasing promising phase 2b study results and innovative drug delivery.

The FDA's ODAC voted that the benefit-risk profile of belantamab mafodotin in multiple myeloma were not favorable, highlighting notable ocular toxicities and missed opportunities for dosing optimization.

FDA grants orphan drug designation to ICT01, a promising immunotherapy for acute myeloid leukemia, targeting unmet needs in older patients.

FDA issues a complete response letter for glofitamab's second-line DLBCL indication, highlighting ongoing scrutiny in oncology therapy approvals.

FDA designates T-DXd plus pertuzumab as breakthrough therapy for HER2-positive metastatic breast cancer, promising improved survival rates for patients.

FDA fast-tracks DB-1310, a novel HER3-targeting ADC, offering hope for advanced NSCLC patients with unmet treatment needs.

Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete response letter.

Zydus Lifesciences gains FDA tentative approval for generic ibrutinib, enhancing access to vital cancer treatment for patients with CLL, SLL, and WM.

Verastem Oncology's VS-7375 receives FDA fast track designation, offering hope for targeted treatment in KRAS G12D-mutated pancreatic cancer.

FDA prioritizes review of tabelecleucel, a promising therapy for relapsed EBV+ PTLD, offering hope to patients with limited treatment options.

Durvalumab's breakthrough therapy designation offers hope for improved outcomes in early-stage gastric and GEJ cancers, potentially transforming treatment strategies.

MAIA Biotechnology's ateganosine gains FDA fast track status, offering hope for advanced NSCLC patients with limited treatment options.

The FDA has cleared investigational new drug applications for ZW251 and RV‑01, advancing novel treatments for solid tumors in first-in-human trials.