This column summarizes New Drug Applications (NDAs) approved in the
fourth quarter 2015 (November-December 2015). In these two months,
FDA approved 30 NDAs.
Twenty-five (65.8%) NDAs were for small molecules while the remaining
13 (34.2%) were for large molecules. Most of the large molecules were
used in the cancer therapy. In this quarter, 18 companies (47.4%)
receiving NDA approvals were large ...
This column summarizes New Drug Applications (NDAs) from May 2015
to July 2015. In this quarter, FDA approved 26 NDAs.
Monday, November 30, 2015
This column summarizes New Drug Applications (NDAs) for March and
April 2015. In these two months, FDA approved 25 NDAs.
Wednesday, September 30, 2015
Twenty one (75 %) NDA’s were for small molecules while the remaining
seven molecules (25%) were large molecules. Ferric pyrophosphate
citrate (Triferic), from its name, does not seem to be a typical large
molecule. It was considered as a large ...
This column summarizes New Drug Applications (NDAs) for the Fourth quarter 2014 (October through December 2014). In this quarter, FDA approved 46 NDAs.
This column summarizes New Drug Applications (NDAs) for the third quarter 2014 (July through September 2014). In this quarter, FDA approved 38 NDAs.
Thursday, February 05, 2015
New Drug Application (NDA) approval involves various steps including pre-clinical research, investigational new drug application, clinical studies, and NDA review. NDAs can be obtained for new molecules or for existing drug molecules with a new ...
Monday, December 01, 2014
Receiving an approval for a New Drug Application (NDA) is something special for every pharmaceutical company. NDAs can be obtained for new molecules or for existing drug molecules with a new formulation
or for a new indication. In this column, we ...
For biopharmaceutical manufacturing, the greatest current
change is the impact of increasing expression levels on the
volume of capacity that is required for production.