FDA Accentuates Venclexta Superiority To Imbruvica
FDA denied breakthrough therapy request until AbbVie and Roche demonstrated substantial improvement over available treatment in 17p deletion chronic lymphocytic leukemia, review documents show.
You may also be interested in...
Rejection of an RMAT request does not mean necessarily mean the FDA won't grant one. The agency will accept new clinical data to support the application through a “reconsideration” process, industry official says.
A year in our long-running series of deep dives into FDA review documents.
US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews
The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.