The drug combo is the first dual checkpoint inhibitor therapy approved in Europe for first-line metastatic MSI-H or dMMR colorectal cancer.

Alyftrek is approved as a new treatment for cystic fibrosis, while the FDA expanded the label for Trikafta to include additional genetic mutations.

NEW YORK – AstraZeneca on Monday said the European Commission approved its tyrosine kinase inhibitor Tagrisso (osimertinib) as a treatment for patients with advanced, unresectable non-small cell lung ...

NEW YORK – 2024 was a banner year of "firsts" in the gene therapy space, as the US Food and Drug Administration greenlit ...

AI-driven tools for prescreening patients, predicting responses and outcomes, and guiding patient therapy are maturing and entering the market.

SAN ANTONIO – In a global study involving more than 5,000 women, risk-reducing surgeries significantly improved survival and ...

R-targeted therapy PMB-CT01 for treating B-cell malignancies, including heavily pretreated follicular lymphoma.

A stem cell transplant added to Rituxan did not improve survival for MRD-negative MCL patients in their first remission ...

The company separately said it has started treating patients within a Phase III trial testing an ASO drug for Angelman syndrome.

The firms are developing the autologous CAR T-cell therapy IB-T101 as a treatment for clear cell renal cell carcinoma.

The firm plans to launch trials to study the agent in biomarker-defined cancer types, including breast and lung cancers.

The agency's decision not to approve this formulation was based on issues identified during a pre-approval inspection at a manufacturing facility, the firm said.