USFDA grants Orphan Drug Designation (ODD) to Zydus’ Desidustat for treatment of beta-thalassemia
Zydus, a leading, discovery-based, global pharmaceutical company announced that the USFDA has granted Orphan Drug Designation…
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Browsing Tag
Orphan Drug Designation
Redx will become a key upcoming player in IPF treatment with FDA’s ODD for zelasudil: GlobalData
KOLs interviewed by GlobalData noted that there is a huge unmet need in the IPF space, which is pushing companies to look for…
Zydus announces Phase IV EVIDENCES-XI trial to generate RWE of Saroglitazar Mg in NAFLD patients…
Phase IV EVIDENCES- XI trial will enroll approximately 1500 NAFLD patients with comorbidities
Zydus gets Orphan Drug Designation from USFDA for ZYIL1 to treat Cryopyrin Associated Periodic…
Orphan drug designation by USFDA for ZYIL1 provides eligibility for certain development incentives, including tax credits for…
Ideaya Biosciences receives ODD for Darovasertib for treating uveal melanoma
Under the ODD, Ideaya may be entitled to certain tax credits, exemption from user fees, and seven years of statutory marketing…
US FDA grants Orphan Drug Designation to BCMA CAR-T cell therapy co-developed by Innovent Biologics…
ODD will accelerate drug development and registration action in the US
Theseus Pharmaceuticals receives US FDA Orphan Drug Designation for THE-630 to treat Advanced…
For patients living with GIST, progression through standard lines of therapy is often associated with the emergence of resistance…
Zydus receives Orphan Drug Designation from US FDA for malaria treatment
The Orphan Drug Designation provides up to seven years of marketing exclusivity in the US
Evrysdi from ROCHE gets EC nod as home treatment for spinal muscular atrophy
The approval is based on data from two clinical studies, designed to represent a broad spectrum of people living with SMA:…
US FDA grants Orphan Drug Designation to Zydus’ Saroglitazar for primary biliary cholangitis…
This follows the grant of ‘Fast Track Designation’ by the USFDA to Saroglitazar Mg for PBC in December 2020