AbbVie has announced the U.S. Food and Drug Administration (FDA) approval for RINVOQ (upadacitinib) to treat refractory, moderate to severe atopic dermatitis in children 12 years and older and adults. Atopic dermatitis, more commonly known as eczema, is a chronic skin...
The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for Aramis Biosciences’ immunomodulatory agent, A197, for the treatment of dry eye disease. Dry eye disease is a common, chronic, immune-mediated disease that is...
The U.S. Food and Drug Administration (FDA) has granted both a Fast Track Designation and a Regenerative Medicine Advanced Therapy Designation (RMAT) to Cellular Biomedicine’s (CBMG) autologous b-specific therapy, C-CAR039, for the treatment of patients with diffuse...
SNIPR BIOME has announced the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug (IND) application for SNIPR001 to target E. coli infections in cancer patients. E. coli bacteria live in the intestines of healthy people and while most...
The European Commission (EC) has granted a conditional marketing authorization for Amgen’s LUMYKRAS (sotorasib) to treat advanced non-small cell lung cancer (NSCLC) with the KRAS G12C mutation in adults. NSCLC is the leading lung cancer diagnosis globally and includes...
The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Otsuka and H. Lundbeck’s drug REXULTI for the treatment of schizophrenia in pediatric patients aged 13 to 17. Schizophrenia is a life-long serious disease that is...
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