Research & Development
Veristat Touts Support for 12% of all FDA NME Approvals in 2018, a Record-Setting Year for FDA Approvals
8 January 2019 - - US-based clinical development and regulatory submission partner Veristat supported its biopharmaceutical clients on 12% of the US Food and Drug Administration approvals granted in 2018, a record-setting year, the company said.

In 2018, the FDA approved 59 drug and biologics therapeutic submissions for New Molecular Entities 1.

Veristat provided strategic planning as well as statistical analysis and medical writing for 12% of those approvals, including breakthrough oncology products as well as therapies for rare genetic-based disorders and infectious diseases.

Over the past 10 years, Veristat has prepared regulatory submissions for nearly 7% of all the NMEs approved by the FDA.

In that time, the company's teams supported a total of 56 global regulatory submission projects.

Of those, 40 have received approvals to date from the FDA, the European Medicines Agency, Health Canada and the Pharmaceuticals and Medical Devices Agency of Japan in a wide range of therapeutic areas, with many pending.

Approvals from 2018 included Tibsovo, the first and only targeted therapy for adult patients with relapsed/refractory Acute Myeloid Leukemia and an IDH1 mutation, and Onpattro (patisiran), a lipid complex injection for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.


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