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

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

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

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

The safety and efficacy outcomes of a total of 3 CD19-directed CAR T-cell therapies were confirmed with other real-world data ...

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 ...

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 ...

Label changes remove Risk Evaluation and Mitigation Strategy programs and eases monitoring requirements, supporting broader ...

Glenmark shares on Monday ended 0.68% up at ₹1,600.85 apiece on BSE. New Delhi: Glenmark Pharmaceuticals on Monday said it ...

In a first for the bloc, Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing ...

The US Food and Drug Administration (FDA) has granted approval to a tablet formulation of BeOne Medicines’ targeted cancer ...