The US Food and Drug Administration (FDA) has granted breakthrough device designation for Acrivon Therapeutics’ ACR-368 ...
The FDA approved Datroway to treat metastatic or unresectable HR+/HER2- breast cancer in people who have tried standard chemo ...
Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
But experts say the regulator needs to reevaluate the safety of other food dyes too. Data suggests that dyes impact child ...
A treatment for patients living with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care (SOC ...
Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...
Ariceum Therapeutics, a private biotech company based in Berlin, has announced that the US Food and Drug Administration (FDA) ...
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult pat ...
FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.
Astra is due to pay Daiichi US$175 million in milestones after the US approval, the companies said. Enhertu is cleared in the ...
The Food and Drug Administration has removed webpages about diversity and inclusion in clinical trials for cancer drugs. The page for Project Equity, a 2021 initiative launched by the FDA's ...