资讯

BioSpace4 小时
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
BioSpace6 小时
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 ...
BioSpace7 小时
Moderna Wins Full Approval for COVID-19 Shot for Higher-Risk Kids
The approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory ...
BioSpace8 小时
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 ...