You are here: Industry Insights > NME

News List

Growing opportunities in API manufacturing as innovative biologic approvals increase: GlobalData expresspharma
May 13, 2021
The US Food and Drug Administration (FDA) approved more biologic new molecular entities (NMEs) in 2020 than in any other year in the previous decade, while at the same time, sponsors increased the outsourcing of these biologics’ active pharmaceutical ...
FDA new drug approvals down 16 percent in 2019, impacting outsourcing europeanpharmaceuticalreview
May 14, 2020
A new report has found that in 2019 the FDA approved 119 new drugs and biologics, but that this is down from 137 in 2018, impacting contract manufacturing organisations.
Special Report—2 years after sluggish 2016, new drug approvals hit their stride in 2018 fiercebiotech
January 04, 2019
If in 2017, the FDA was trying to make up for lost time, the agency went into overdrive in 2018, approving more than 50 new molecular entities.....
FDA hails 2018 as bumper year for drug development successes fiercebiotech
December 26, 2018
The FDA has hailed 2018 as a standout year for drug development and approvals, both in terms of the quantity and quality of activity.....
Review: Summary and Analysis of the Novel Drug Approvals of FDA in the First Three Quarters of 2017 en-cphi.cn
November 16, 2017
The total number approved in the first three quarters far exceeded that approved in 2016 (FDA approved 22 original novel drugs in total in 2016, including 15 NMEs and 7 BLAs).