Spring Awakening: NDA Submissions To Watch For
If companies meet their publicly stated NDA filing targets, at least four breakthrough-designated therapies will arrive at US FDA in March.
You may also be interested in...
Keeping Track: Mylan Wins First US FDA Approval For Neulasta Biosimilar, But Lands A CRL For Insulin Glargine; Genentech Nabs Broad Full Approval For Venclexta, PV Indication For Rituxan
The latest drug development news and highlights from our US FDA Performance Tracker.
Orphan Designations For Cancer Drugs: US FDA Urged To Distinguish Tissue-Agnostic From Tumor-Specific Diseases
Generic and brand firms both seem to want ‘very black and white lines’ on orphan exclusivity, but FDA isn't so sure how to distinguish biomarker-targeted disease from histologically-defined disease.
US FDA's oncology advisory committee seems to feel Blincyto has potential in minimal residual disease-positive acute lymphoblastic leukemia, but panel was not asked specifically about approval; a decision could hinge on how agency reviewers interpret committee's comments.