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Capricor Plunges on FDA Rejection of DMD Cell Therapy
In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...
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FDA’s Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
Glenmark arm inks $700 million licensing deal with US-based AbbVie
Glenmark's arm IGI Therapeutics signs a $700 million licensing deal with AbbVie for its cancer drug ISB 2001, with potential ...
The FDA Just Launched an AI Tool That Could Change How Food Recalls Happen
The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, ...