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 ...

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.

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 ...

The FDA delivered two notable approvals for RSV immunization, UroGen overcame a negative advisory committee vote to secure an ...

Adaptive Biotechnologies Corporation (NASDAQ: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and ...

Relapsed/refractory peripheral and cutaneous T-cell lymphomas (R/R PTCL and CTCL) are aggressive blood cancers that often ...

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