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Recent FDA decisions added new options for dermatologists involved in treating patients with psoriasis, bullous pemphigoid ...
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult ...
It is the first biosimilar of a rapid-acting insulin product – used to control the blood glucose spike after meals – and only the third insulin biosimilar to be approved in the US.
Amgen’s Bkemv is first FDA-approved biosimilar to AstraZeneca’s Soliris in the US, getting interchangeable status for rare diseases PNH and aHUS.
Online Correspondence Published: March 2007 Biosimilars: the impact of their heterogeneity on regulatory approval Asterios S Tsiftsoglou Nature Reviews Drug Discovery 6, 252 (2007) Cite this article ...
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