September 2025 Briefs

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

The FDA approves Bildyos and Bilprevda, expanding treatment options for osteoporosis and cancer-related bone loss, enhancing patient access and affordability.

Lantern Pharma advances pediatric CNS cancer treatment with FDA guidance on LP-184 trial, targeting rare tumors and enhancing therapy with spironolactone.

FDA fast-tracks CER-1236, a novel immunotherapy for acute myeloid leukemia, enhancing its development and potential market entry.

Rezolute streamlines the clinical pathway for ersodetug, expediting treatment for tumor hyperinsulinism and addressing urgent patient needs.

FDA grants orphan drug designation to BA-101, a promising treatment for glioblastoma, aiming to improve outcomes in this challenging cancer.

FDA designates olomorasib and pembrolizumab as breakthrough therapy for advanced KRAS G12C-mutant lung cancer, showing promising response rates in trials.

The FDA approves Inlexzo, a groundbreaking treatment for bladder cancer, offering hope for patients unresponsive to traditional therapies.

The FDA approves selumetinib for young patients with neurofibromatosis type 1, offering hope for effective treatment of inoperable tumors.

FDA fast tracks GLSI-100 for HER2-positive breast cancer, promising new hope for patients with unmet medical needs. Discover its potential benefits.

FDA accepts relacorilant and nab-paclitaxel for platinum-resistant ovarian cancer, showing promising survival benefits in recent trials.

BioAtla's ozuriftamab vedotin advances to phase 3 trials for HPV-positive oropharyngeal cancer, aiming for accelerated FDA approval amid rising incidence.

FDA designates raludotatug deruxtecan as a breakthrough therapy for treating platinum-resistant ovarian cancers, enhancing patient care options.

Ligufalimab receives FDA orphan drug designation for AML, showcasing promising efficacy and safety in treating hematologic malignancies and solid tumors.

The FDA fast-tracks CRB-701, an innovative ADC for advanced head and neck cancer, showing promising efficacy and safety in ongoing trials.

The FDA approved Bosaya and Aukelso biosimilars, enhancing options for cancer-related bone loss, including in patients with multiple myeloma.

MNV-201 gains FDA fast track designation for myelodysplastic syndromes, promising expedited development and potential breakthroughs in treatment.

The FDA approves subcutaneous pembrolizumab, enhancing treatment efficiency for solid tumor treatment while maintaining safety and efficacy.

The FDA approves a new diagnostic kit for identifying acute leukemia patients eligible for the groundbreaking Menin inhibitor, revumenib.

FDA prioritizes review of T-DXd for first-line HER2-positive breast cancer treatment, showcasing significant survival benefits in recent studies.

The FDA approves imlunestrant, offering a new oral treatment option for advanced ER-positive breast cancer, enhancing patient outcomes and management.

FDA lifts REMS program for vandetanib, affirming safety in thyroid cancer treatment as healthcare providers ensure effective heart rhythm monitoring.

FDA approves imlunestrant for advanced breast cancer, enhancing treatment options for patients with ESR1 mutations through innovative genomic profiling.

Umoja Biopharma's UB-VV111 receives FDA fast track designation, advancing CAR T cell therapy for relapsed/refractory B-cell malignancies.