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 ...
NEW YORK – Ultragenyx Pharmaceutical on Thursday said it has submitted a biologics license application to the US Food and Drug Administration seeking accelerated approval for UX111 as a gene therapy ...
AI-driven tools for prescreening patients, predicting responses and outcomes, and guiding patient therapy are maturing and entering the market.
NEW YORK – The US Food and Drug Administration on Friday granted accelerated approval to Pfizer's Braftovi (encorafenib) plus Eli Lilly's Erbitux (cetuximab) with chemotherapy for patients with newly ...
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.
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