Saturday, February 10, 2018
This column summarizes newly approved drugs and new indications and
patient population for already approved drugs from June to September
2017. This includes New Drug Applications (NDAs), Biologics Licensing
Applications (BLAs) and Biosimilar ...
Saturday, February 10, 2018
Testosterone is a male sex hormone produced in the testicles. With the
onset of puberty in males, testosterone secretion is responsible for a
number of physiologic changes including increase in genital size, changes
in hair growth, increase in ...
Thursday, December 07, 2017
This column summarizes newly approved drugs and new indications for already approved drugs from February to May 2017. This includes New Drug Applications (NDAs) for small molecules, Biologics Licensing Applications (BLAs), Medical devices and ...
Monday, September 25, 2017
Over the last 20 years, the PDUFA has authorized the USFDA to collect user fees from industry to facilitate the review process for certain human drug applications.
This column summarizes New Drug Applications (NDAs) approved in the November-December 2016 and January 2017. FDA approved 30 NDAs in these three months.
This column summarizes New Drug Applications (NDAs) approved in the September-October 2016 timeframe. FDA approved 20 NDAs in these two months.
This column summarizes New Drug Applications (NDAs) approved from July-August 2016. FDA approved 21 NDAs in these two months.
Wednesday, February 01, 2017
This column summarizes New Drug Applications (NDAs) approved in May-June 2016. FDA approved 24 NDAs in these two months.
Sunday, November 20, 2016
This column summarizes New Drug Applications (NDAs) approved
in the second quarter 2016 (May-June 2016). In this quarter, FDA
approved 23 NDAs.
Friday, September 30, 2016
This column summarizes New Drug Applications (NDAs) for January-February, 2016. In these two months, FDA approved 25 NDAs.