We’ve launched a first-of-its-kind app to help you find out where your generic drugs come from and see the track records of ...
Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — The Food and Drug ...
The next time the FDA turns down a drug application, the letter outlining the decision and the regulator’s reasoning will become public record. The agency said it will release future complete response ...
To hear health officials in the Trump administration talk, artificial intelligence has arrived in Washington to fast-track new life-saving drugs to market, streamline work at the vast, ...
The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
The FDA is reviewing the supplemental BLA for lisocabtagene maraleucel (liso-cel), a CD19-directed genetically modified autologous T cell immunotherapy, for relapsed or refractory (R/R) marginal zone ...
With every bottle of prescription medication comes an implied promise: The drugs are safe and effective and meet strict standards set by the Food and Drug Administration. But the agency known as one ...
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