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Big picture: This approval marks a step toward affordable access to advanced therapies, but the ongoing patent challenges will play a key role in shaping market dynamics

The study had certain criteria that excluded individuals who had severe liver or renal impairment (defined as serum alanine transaminase (ALT) 3-fold the upper limit of normal

Histamine intolerance happens when there is a deficiency of the enzymes that break down histamine leading to excess histamine and a variety of health problems