FDA grants a priority review for a Roche sBLA for Espryng to treat myelin oligodendrocyte glycoprotein antibody-associated disease, an autoimmune disease with no approved treatments.
BMC Medical recalls its Luna G3 APAP (Model LG3600), an auto-adjusting positive airway pressure machine for treating obstructive sleep apnea, due to a firmware defect.
FDA grants a priority review for a Roche sBLA for Espryng to treat myelin oligodendrocyte glycoprotein antibody-associated disease, an autoimmune disease with no approved treatments.
BMC Medical recalls its Luna G3 APAP (Model LG3600), an auto-adjusting positive airway pressure machine for treating obstructive sleep apnea, due to a firmware defect.
FDA issues a partial clinical hold on Biohaven’s opakalim (BHV-7000) due to “nonclinical characterization of certain metabolites” documented in rodent testing.
FDA releases the Form FDA-483 with three observations from an inspection at New Albany, OH-based XeCare.
