The Food and Drug Administration (FDA) has authorized marketing of a new diagnostic test, cobas vivoDx MRSA (Roche Molecular Systems Inc), to detect methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization and aid in the prevention and control of MRSA infections in healthcare settings. The cobas vivoDx MRSA test provides rapid phenotypic detection of MRSA colonization through…
N-803 is an IL-15 superagonist complex consisting of an IL-15 mutant bound to an IL-15 receptor α/IgG1 Fc fusion protein
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 14 to 2 against the approval of empagliflozin 2.5mg as an adjunct to insulin for adults with type 1 diabetes.
Allena Pharmaceuticals announced positive topline results from the phase 3 URIROX-1 trial of reloxaliase for the treatment of enteric hyperoxaluria (EH), as well as additional data from the phase 2 trial (Study 206) in high-risk patients with EH and advanced chronic kidney disease (CKD). Reloxaliase is a first-in-class, crystalline formulation of the enzyme oxalate decarboxylase…
The FDA has granted Fast Track designation to TERN-101 (Terns Pharmaceuticals) for the treatment of non-alcoholic steatohepatitis.
Mylan Pharmaceuticals announced the voluntary recall of one lot of alprazolam 0.5mg tablets to the consumer/user level due to the potential presence of a foreign substance.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to SFA001 (SFA Therapeutics) for the treatment of hepatocellular carcinoma (HCC). SFA001 is an investigational microbiome-derived drug that is developed from natural substances using the Company’s proprietary discovery process to match metabolites and adjuvants to treat chronic inflammatory diseases. The designation is based on…
