More than 13 years after its initial FDA approval, Pfizer’s blood cancer drug Adcetris has nabbed another regulatory green ...
A new FDA approval stands to give Daiichi Sankyo’s Turalio some company in a rare tumor type. | The new FDA approval gives Daiichi Sankyo’s Turalio some company in a rare tumor type.
The FDA approved Datroway to treat metastatic or unresectable HR+/HER2- breast cancer in people who have tried standard chemo ...
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status ...
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Pfizer’s Takeda-partnered blood cancer drug Adcetris (brentuximab vedotin) has been approved by the US Food and Drug ...
Roche has received FDA approval for a label expansion of its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which identifies patients with HR–positive, HER2-ultralow metastatic ...
Ezra, the healthcare AI startup revolutionizing early cancer detection through full-body MRI screening, today announced new 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its ...
Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with so-called “HER2-ultralow” status. The company’s PATHWAY HER2 ...
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for ...