Shots: The MAA submission is based on a P-Ib/II CARTITUDE-1 study assessing the safety and efficacy of cilta-cel in adults with r/r MM. The company is expected to submit MAA […]readmore
Tags : Assessment
Biosimilars
Biotech
Regulatory
The US FDA Releases Drafts Guidance Recommending on Comparative Analytical
Shots: The US FDA has released guidance on the design and evaluation of comparative analytical studies that are supporting demonstration of biosimilarity, with the withdrawn of previous draft guidance approach […]readmore