Orphan Drug Designation

KOLs interviewed by GlobalData noted that there is a huge unmet need in the IPF space, which is pushing companies to look for…

Phase IV EVIDENCES- XI trial will enroll approximately 1500 NAFLD patients with comorbidities

Orphan drug designation by USFDA for ZYIL1 provides eligibility for certain development incentives, including tax credits for…

Under the ODD, Ideaya may be entitled to certain tax credits, exemption from user fees, and seven years of statutory marketing…

ODD will accelerate drug development and registration action in the US

For patients living with GIST, progression through standard lines of therapy is often associated with the emergence of resistance…

The Orphan Drug Designation provides up to seven years of marketing exclusivity in the US

The approval is based on data from two clinical studies, designed to represent a broad spectrum of people living with SMA:…

This follows the grant of ‘Fast Track Designation’ by the USFDA to Saroglitazar Mg for PBC in December 2020

The company is focused on developing novel biologics and biosimilars