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news.Bio-Thera Solutions’ BAT1806 receives China NMPA approval
Bio-Thera Solutions has received approval for the biosimilar of Actemra (tocilizumab), BAT1806, from the National Medical Products Administration (NMPA) of China.
Musculoskeletal Disorders
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17 Jan 2023
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10 Jan 2023
US FDA accepts Santhera, ReveraGen’s vamorolone NDA to treat DMD
Santhera Pharmaceuticals and ReveraGen BioPharma have announced the acceptance of vamorolone’s new drug application (NDA) for filing by the US Food and Drug Administration (FDA) to treat Duchenne muscular dystrophy (DMD).
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13 May 2022
Stealth receives FDA orphan drug designation for elamipretide to treat DMD
Stealth BioTherapeutics has received Orphan Drug Designation from the US Food and Drug Administration (FDA) Office of Orphan Products Development for elamipretide to treat Duchenne muscular dystrophy (DMD) patients.