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
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Browsing Tag
Orphan Drug Designation
Xentria gets US FDA orphan drug designation for XTMAB-16 in sarcoidosis
The company is focused on developing novel biologics and biosimilars
USFDA approves Inmazeb from Regeneron Pharma to treat Ebola
It is a mixture of three monoclonal antibodies, and the first FDA-approved treatment for Ebola virus infection in adult and…
TSHA-102 from Taysha gets rare paediatric disease and orphan drug designations for Rett syndrome
Taysha anticipates that it will submit an Investigational New Drug (IND) application for TSHA-102 to the FDA in 2021
Trodelvy from Immunomedics gets US FDA orphan drug designation for glioblastoma
Trodelvy has shown encouraging activity in an early-stage study in brain cancers, including partial responses in small cohorts of…
US FDA grants orphan drug designation to oNKord from Glycostem for multiple myeloma
The designation will provide Glycostem with eligibility for seven years of market exclusivity and clear FDA guidance on specific…
USFDA approves Nucala to treat hypereosinophilic syndrome
The approval granted to GlaxoSmithKline is the first approval for HES patients in nearly 14 years
US FDA grants Lupin’s Mexiletine Orphan Drug Designation
Myotonic disorders are a group of heterogeneous, inherited, neuromuscular disorders characterized by a shared symptom called…
SPARC gets orphan drug designation for Phenobarbital from US FDA
Orphan Drug Designation will grant seven years of US market exclusivity upon approval of Phenobarbital for the treatment of…
Glenmark receives Orphan Drug Designation for GBR 1342
The drug is indicated for the treatment of multiple myeloma
Glenmark Pharmaceuticals (Glenmark), announced that the US Food and…