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

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

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 ...

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.

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

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

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

The drugmaker said that the agents vibostolimab and favezelimab failed to show benefit across numerous trials.

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.

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