Chris Ryan

The FDA granted a complete response letter with no safety concerns for the new drug application for TLX101-CDx’s use in glioma imaging.

Findings from the phase 1 BrainChild-03 trial support breakthrough designation for BCB-276 for pediatric diffuse intrinsic pontine glioma.

Gene expression in peripheral blood as well as patient-reported outcomes differed for those with acute myeloid leukemia undergoing induction chemotherapy.

Neoadjuvant and adjuvant durvalumab plus FLOT followed by durvalumab monotherapy improved EFS for patients with resectable gastric or GEJ cancer.

Clinical response rates were higher in patients with phlebotomy-dependent polycythemia vera who received rusfertide than in those who received placebo.

T-DXd delivered an OS benefit for patients with unresectable or metastatic HER2-positive gastric and GEJ adenocarcinoma following trastuzumab-based treatment.

The FDA granted petosemtamab plus pembrolizumab breakthrough therapy status for PD-L1–positive recurrent/metastatic head and neck squamous cell carcinoma.

Amezalpat has been granted FDA fast track designation as treatment for patients with hepatocellular carcinoma.

Serial CTRS, an AI-powered tool, has been granted FDA breakthrough device designation for classifying patients with NSCLC.

After a phase 3 study showed a promising pCR rate with HLX11, the pertuzumab biosimilar’s BLA has been accepted for review by the FDA.

The FDA has approved a companion diagnostic to determine if patients with HR-positive, HER2-ultralow metastatic breast cancer are eligible for T-DXd treatment.

Sintilimab with neoadjuvant chemoradiotherapy enhanced pCR rates in resectable, locally advanced esophageal squamous cell carcinoma.

Preoperative sintilimab with chemoradiotherapy boosted pathological complete response rates in patients with resectable, locally advanced esophageal squamous cell carcinoma.

Nivolumab plus chemotherapy improved long-term survival in Chinese patients with advanced gastric, GEJ, or esophageal cancer.

The FELIX trial demonstrated that obe-cel induced durable remissions in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Sasanlimab plus BCG improved outcomes in high-risk, BCG-naive non-muscle-invasive bladder cancer.

A new drug application has been submitted to the FDA for dordaviprone to treat recurrent H3K27M-mutant diffuse glioma.

Nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) was approved by the FDA for subcutaneous injection across approved solid tumor indications for nivolumab (Opdivo).

The FDA approved tislelizumab plus chemotherapy for the first-line treatment of unresectable or metastatic gastric or GEJ adenocarcinoma.

Lunresertib plus camonsertib showed promising efficacy in advanced endometrial and platinum-resistant ovarian cancers, with ORRs of 25.9% and 37.5%, respectively.

The FDA has granted approval for the use of encorafenib in combination with cetuximab and mFOLFOX6 for the treatment of metastatic colorectal cancer harboring a BRAF V600E mutation.

Patients administered lymphodepletion prior to brexu-cel in the outpatient setting experienced a 60-day non-relapse mortality rate of 3.6% in B-ALL and MCL.

Imlunestrant, alone or in combination, may provide an all-oral, targeted therapy option following progression for patients with ESR1-mutant, ER-positive, HER2-negative advanced breast cancer.

The NCCN Guidelines Version 1.2025 for Cancer of the Nasopharynx listed toripalimab plus chemotherapy as the standalone preferred regimen in the frontline treatment of patients with advanced nasopharyngeal carcinoma.

The FDA approved an oral solution of imatinib for multiple different cancer types.

The FDA accepted a supplemental new drug application to darolutamide plus androgen deprivation therapy for metastatic hormone-sensitive prostate cancer.

The FDA granted an accelerated approval to zanidatamab-hrii for previously treated, unresectable or metastatic HER2-positve biliary tract cancer.

The FDA granted a fast track designation to ALE-P02 for patients with CLDN1-positive squamous solid tumors.

The FDA approved ninlotinib tablets that do not have mealtime restrictions for Ph-positive CML in chronic phase and CML that was previously treated.