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The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided a rare glimpse in | ...
In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...
Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...
A court battle between Regeneron and Amgen is testing the legal limits of how far drugmakers can go in using patents to ...