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When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided a rare glimpse in | ...
The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...
A court battle between Regeneron and Amgen is testing the legal limits of how far drugmakers can go in using patents to ...
Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...