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U.S. FDA Grants Orphan Drug Designation to BCMA CAR-T Cell Therapy Co-Developed by IASO Bio and Innovent prnasia
February 14, 2022
IASO Biotherapeutics ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, and Innovent Biologics, Inc.
CTB001, Bioheng auto CAR - T Product, received Orphan Drug Designation (ODD) from the U.S. FDA prnasia
January 29, 2022
Recently, Nanjing Bioheng Biotech Co., Ltd. ( hereinafter referred to as Bioheng) announced that its anti-claudin 18.2 autologous CAR-T cell therapy product CTB001 received Orphan Drug Designation (ODD) from the Food...
Senhwa Biosciences receives ODD for Silmitasertib from FDA to treat biliary tract cancer pharmaceutical-business-review
January 21, 2022
Senhwa Biosciences has announced the receipt of Orphan Drug Designation (ODD) from the US Food and Drug Administration...
FDA Grants Longeveron Orphan Drug Designation for Lomecel-B in Infants with Hypoplastic Left Heart Syndrome AmericanPharmaceuticalReview
December 07, 2021
Longeveron Inc., a clinical-stage biotechnology company developing cellular therapies for chronic aging-related and certain life-threatening conditions, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD)
Subcutaneously Injected PD-L1 Antibody Envafolimab (KN035) Obtained Its Second Orphan Drug Designation From The U.S. FDA prnasia
June 30, 2021
Alphamab Oncology announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to envafolimab (KN035), a recombinant humanized PD-L1 single-domain antibody independently invented by Alphamab Oncology ...
Bioheng Biotech received Orphan Drug Designation from the U.S. FDA for the treatment of T-ALL. prnasia
June 21, 2021
Nanjing Bioheng Biotech Co., Ltd. Announced UCAR T cell therapy product targeting CD7, code CTD401, received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of T-cell acute lymphoblastic leukemia.
Bioheng Biotech received Orphan Drug Designation from the U.S. FDA for the treatment of T-ALL firstwordpharma
June 21, 2021
Nanjing Bioheng Biotech Co., Ltd. Announced UCAR T cell therapy product targeting CD7, code CTD401, received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of T-cell acute lymphoblastic leukemia (T-ALL).
InnoCare Announces Orphan Drug Designation of Gunagrabtinib by US FDA for Treatment of Cholangiocarcinoma prnasia
June 17, 2021
InnoCare, a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its pan-FGFR inhibitor gunagratinib (ICP-192) for the ...
Neurogene announces EMA grants orphan drug designation for aspartylglucosaminuria gene therapy pharmaceutical-business-review
December 09, 2020
Neurogene announces that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) to its adeno-associated virus vector (AAV) with engineered transgene encoding the human AGA gene for patients diagnosed with aspartylglucosaminuria.
AskBio, Selecta Biosciences Receive ODD for Methylmalonic Acidemia Treatment americanpharmaceuticalreview
December 04, 2020
Asklepios BioPharmaceutical and Selecta Biosciences announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to MMA-101, an AAV-based gene therapy in development for the treatment of isolated methylmalonic acidemia ...

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