pharmaphorum

DECEMBER 12, 2022

Dutch biotech Argenx is on course to add another rare disease indication to the label of its FcRn blocker Vyvgart – primary immune thrombocytopenia (ITP) – thanks to new data reported at the ASH annual meeting. Analysts have said that Vyvgart could reach blockbuster sales of $2 billion or more if available in a subcutaneous version.

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Immunization Labelling FDA 52

PharmaShots

JUNE 23, 2023

Gilead Receives EMA’s CHMP Positive Opinion of Trodelvy (sacituzumab govitecan) for Pre-Treated HR+/HER2- Metastatic Breast Cancer Date: June 23, 2023 | Tags: Gilead, Trodelvy, sacituzumab govitecan, HR+/HER2- Metastatic Breast Cancer, Regulatory, EMA, CHMP, Positive Opinion Sarepta Therapeutics’ Elevidys Receives the US FDA’s Accelerated (..)

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FDA 40

pharmaphorum

MARCH 23, 2022

Argenx only recently scored FDA approval for its intravenous anti-neonatal FC receptor (FcRn) antibody Vyvgart for generalised myasthenia gravis (gMG), but is already looking to defend its franchise with a new subcutaneous version of the drug. Preliminary results from UCB’s phase 3 RAISE study are expected in the coming weeks.

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FDA 52