Adults with mantle cell lymphoma who have already failed two or more treatments, including a BTK inhibitor, now have a new targeted option. The FDA granted accelerated approval to sonrotoclax, sold ...
The FDA has moved to pull Tavneos (avacopan) from the U.S. market, alleging that manipulated clinical trial data propped up the drug’s 2021 approval for a rare and potentially fatal blood vessel ...
In this analysis, researchers sought to assess the impact of the 21st Century Cures Act, which gave the FDA increased flexibility to accept a single pivotal trial as the basis for a novel drug ...
Although efforts to revamp the drug-safety system have been directed at strengthening postmarketing surveillance, strategies for the preapproval stage may be useful. One strategy would be to require ...
On February 19, the US Food and Drug Administration (FDA) announced a significant shift in its drug approval framework: A single adequate and well-controlled clinical trial, combined with confirmatory ...
At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with sickle cell disease. While this is good news for children in the U.S. born ...
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to ...
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