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US FDA Grants Orphan Drug Designation (ODD) for Prestige BioPharma’s PBP1510 Anti-PAUF Monoclonal Antibody for the Treatment of Pancreatic Cancer B3C newswire
July 01, 2020
Prestige BioPharma Ltd. (hereinafter “Prestige BioPharma”) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreat
CNS Announces Filing of Orphan Drug Designation for Brain Cancer Drug americanpharmaceuticalreview
April 26, 2020
CNS Pharmaceuticals has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its lead product Berubicin.
FDA grants Orphan Drug Designation to phenylketonuria treatment europeanpharmaceuticalreview
April 08, 2020
A new treatment called APR-OD031 has been given Orphan Drug Designation (ODD) by the FDA, for the treatment of phenylketonuria.
Ryvu Therapeutics Receives Orphan Drug Designation AML Treatment americanpharmaceuticalreview
April 01, 2020
Ryvu Therapeutics announced the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Ryvu's SEL120, for the treatment of patients with acute myeloid leukemia (AML).
EC grants Orphan Drug Designation to FLT190, a Fabry Disease treatment europeanpharmaceuticalreview
March 16, 2020
FLT190 gene therapy has been granted Orphan Drug Designation based on preliminary trial data and the positive opinion of an EMA committee.
Orphan Drug Designations are declining, says market analysis europeanpharmaceuticalreview
March 04, 2020
A report has suggested that number of Orphan Drug Designations in both the US and Europe is declining, possibly due to prices and political changes.
Orphan drugs face uphill battle in 2020: GlobalData expresspharma
March 03, 2020
ODDs have been a focus of interest from the pharma industry for many years, with many companies enticed by the benefits of the enhanced regulatory processes, tax benefits and extended market exclusivity.
FDA grants Avatrombopag Orphan Drug Designation for thrombocytopenia europeanpharmaceuticalreview
January 15, 2020
The US FDA has granted avatrombopag (Doptelet) ODD as around 10 percent of US cancer patients per year experience chemotherapy-induced thrombocytopenia (CIT) with no available treatment.
Tetra Bio-Pharma Receives ODD for Hepatocellular Carcinoma Treatment americanpharmaceuticalreview
December 09, 2019
Tetra Bio-Pharma has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for delta-9-tetrahydrocannabinol (THC) in the treatment of hepatocellular carcinoma.
FDA Grants ODD to Investigational Drug for Epidermolysis Bullosa americanpharmaceuticalreview
December 09, 2019
APR Applied Pharma Research (APR) has announced the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for ...

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