December 2025 Briefs

The IsoPSA test revolutionizes prostate cancer diagnosis, enhancing risk assessment and reducing unnecessary biopsies for men with elevated PSA levels.

The FDA approves pegfilgrastim-unne, enhancing treatment options for cancer patients at risk of febrile neutropenia during chemotherapy.

CLN-049 gains FDA fast track designation, offering hope for patients with relapsed/refractory AML through innovative immunotherapy solutions.

The FDA fast-tracks zotiraciclib for recurrent high-grade gliomas, offering hope for patients with IDH mutations and expanding treatment options.

Pirtobrutinib receives FDA traditional approval for relapsed CLL, showing significant progression-free survival benefits in clinical trials.

FDA approves liso-cel, the first CAR T-cell therapy for relapsed marginal zone lymphoma, offering hope for improved patient outcomes.

The FDA reviews nivolumab with chemotherapy as a potential new frontline treatment for advanced classical Hodgkin lymphoma, promising improved outcomes.

FDA approves a new treatment combining niraparib and abiraterone for BRCA2-mutated metastatic prostate cancer, enhancing patient outcomes.

FDA approves T-DXd plus pertuzumab for HER2-positive metastatic breast cancer, showing significant improvements in progression-free survival and response rates.

FDA grants a priority voucher for Tec-Dara, showcasing significant survival benefits in relapsed/refractory multiple myeloma, enhancing treatment options.

Roxadustat receives orphan drug designation for myelodysplastic syndromes, highlighting its potential to improve transfusion independence in patients.

FDA fast-tracks muzastotug and pembrolizumab for metastatic colorectal cancer, showcasing promising efficacy and safety in early studies.

Rucaparib receives full FDA approval for treating metastatic castration-resistant prostate cancer, offering a vital chemotherapy-free option for patients.

The FDA approves a new subcutaneous formulation of amivantamab, enhancing treatment for advanced lung cancer with reduced administration time and improved safety.

The FDA fast-tracks BGB-B2033, a promising bispecific antibody, for advanced hepatocellular carcinoma, enhancing treatment options for patients.

FDA approves CBI-1214 for colorectal cancer, enabling fast-tracked clinical trials and highlighting innovative T-cell engager technology.

FDA designates T-DXd as breakthrough therapy for high-risk HER2-positive early breast cancer, promising improved survival rates over current treatments.

JSKN003, a novel HER2-targeting ADC, shows promising efficacy in treating platinum-resistant ovarian cancer, earning FDA breakthrough therapy designation.

FDA approves mosunetuzumab-axgb for quick subcutaneous treatment of relapsed follicular lymphoma, enhancing patient care and reducing clinic time.