that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval for an indication extension of IMBRUVICA ® ...

Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been ...

Beerse: Janssen-Cilag International NV, a Johnson & Johnson company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued ...

Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...

In a cohort of TRANSCEND FL, the chimeric antigen receptor T-cell therapy liso-cel showed a 95% overall response rate in ...

Breaking down what patients should know about each FDA therapeutic approval from June 2025 across various oncology ...

The FDA has approved updated labels for Breyanzi and Abecma, removing the REMS programs and reducing certain restrictions.

To begin with, this trial recruited 12 people with mantle cell lymphoma that had come back after treatment. They all had ofatumumab through a drip into a vein, once a week for up to 5 weeks. When the ...

The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.

SGR-1505 was designed using Schrödinger's computational platform at scale and was discovered approximately 10 months after the company started its MALT1 program. A Phase 1 study in patients with ...

Breyanzi demonstrated a 95.5% response rate among patients with relapsed/refractory marginal zone lymphoma, as well as a ...