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Agios seeks FDA nod to expand mitapivat label in sickle cell disease
Agios Pharmaceuticals AGIO announced that it has submitted a supplemental new drug application (sNDA) to the FDA seeking ...
FDA’s final SIUU guidance loosens some off-label communication rules, but drugmakers still face strict compliance demands to ...
The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors in evaluating drug safety during ...
The label expansion will include adults with AChR-Ab-negative gMG, making efgartigimod the first and only approved treatment for all serotypes of the rare neuromuscular disease.
Axsome Therapeutics (AXSM) stock is in focus as the FDA OKs a label expansion for the firm's depression drug Auvelity in ...
The FDA is seeking public input on drug repurposing efforts aimed at expanding treatment options for diseases tied to unmet medical needs. The agency said identifying new uses for FDA-approved drugs ...
The U.S. FDA has approved a label expansion for Vyvgart and Vyvgart Hytrulo in myasthenia gravis, letting a broader section of adults suffering from the autoimmune disease receive the therapy, its ...
Clinicians should monitor vitamin B6 levels in Parkinson disease patients taking carbidopa/levodopa due to a risk for deficiency-linked seizures. Reports of seizures linked to vitamin B6 deficiency in ...
The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and ...
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