Biohaven achieves FDA approval with Nurtec™

In February 2020, Biohaven announced that the U.S. Food and Drug Administration (FDA) approved Nurtec™ ODT (rimegepant) for the acute treatment of migraines in adults. It is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting, orally disintegrating tablet (ODT).

Regulatory and Medical Writing

High quality medical and regulatory writing is an essential part of any successful drug development program. Pharmaceutical and biotech companies need a trusted, agile, and experienced partner not only to write these documents, but also to act as a strategic partner and address key issues.

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