Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets
AA, a chronic immune disease, can cause extensive and unpredictable hair loss
The results, published in The Lancet, showed orforglipron delivered significantly greater reductions in both A1C and body weight across primary and key secondary endpoints
The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder
Arcellx develops innovative immunotherapies for cancer and other incurable diseases
Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
Sodium Phosphates Injection is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake
The move follows encouraging Phase I data and a series of regulatory wins from the U.S. Food and Drug Administration
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
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