Search Results for new molecular entities

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Updated: New Drug Approvals for FDA: 2017 Hits 21-Year High By Zachary Brennan - Published 21 December 2017

The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the highest number of NMEs approved in any year except 1996.

Categories: News, US, FDA, Drugs, Government affairs, Submission and registration

Tags: new drug approvals, new molecular entities, Addyi,

Fast Start for FDA Drug Approvals in 2017 By Michael Mezher - Published 12 April 2017

The US Food and Drug Administration (FDA) is poised to make a comeback from the relatively low number of new drugs approved in 2016, though it's unlikely to match the approval highs from 2014 and 2015.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: Approvals, New Molecular Entities, Biologics License Applications

How Many Drugs has FDA Approved in its Entire History? New Paper Explains By Alexander Gaffney, RAC - Published 03 October 2014

Pop quiz: While the US Food and Drug Administration (FDA) approves dozens of drugs each year, how many new drugs—i.e. discounting generic versions of approved drugs—has it approved in its entire existence?

Categories: Biologics and biotechnology, Drugs, Regulatory intelligence

Tags: FDA NME Approvals, New Molecular Entities, Drug Approvals, FDA Drug Approvals