Thursday, September 24, 2020
This quarterly review on New Drug Applications contains data for applications approved for the first time during April-June of 2020, which includes New Molecular Entities (NMEs) and new biologics. A total of 43 applications were approved by FDA ...
This quarterly review on new drug applications contains data for applications approved for the first time during the first quarter of 2020 which includes New Molecular Entities (NMEs) and new biologics. A total of 30 applications were approved by the...
Monday, December 09, 2019
This quarterly review of new drug applications contain data for applications approved for the first time during the third quarter of 2019 which includes New Molecular Entities (NMEs) and new biologics. A total of 36 applications were approved by the ...
Tuesday, September 24, 2019
This quarterly review on new drug applications contain data for applications approved for the first time during the second quarter of 2019 which includes new molecular entities (NMEs) and new biologics. A total of 30 applications were approved by FDA...
This quarterly review on new drug applications contains data for applications approved for the first time during the fourth quarter of 2018 which includes New Molecular Entities (NMEs) and new biologics. A total of 46 applications were approved by ...
Thursday, October 11, 2018
This quarterly review on New Drug Applications (NDAs) contain data for applications approved for the first time during the second quarter of 2018, which includes New Molecular Entities (NMEs) and new biologics.
Wednesday, August 29, 2018
This quarterly review on New Drug Applications contains data for applications approved for the first time during the first quarter of 2018, which includes New Molecular Entities (NMEs) and new biologics. A total of 28 applications were approved by ...
Over the years, the Prescription Drug User Fee Act (PDUFA) has authorized the USFDA to collect user fees from industry to facilitate the review process for certain human drug applications. The fifth authorization of PDUFA (2012-2017) focused mainly ...
This column summarizes newly approved drugs, biologics, new indications and patient populations for already approved drugs from October to December 2017. This includes New Drug Applications (NDAs), Biologics Licensing Applications (BLAs) and ...
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 ...