Articles related to FDA

N-nitroso-duloxetine poses increased cancer risk at higher concentrations and extended exposure periods, prompting FDA-mandated strict limits on nitrosamine levels in medications.

Nearly half of clinical trial participants achieved such significant improvements that their OSA symptoms were effectively resolved, marking a significant advancement in treating this complex disorder.

Subcutaneous administration of amivantamab demonstrated noninferiority to IV delivery while potentially offering enhanced patient convenience and reduced healthcare system burden.

Manufacturing violations at an Indian facility have triggered a recall of 15 million OTC pain patches, raising concerns about product quality and patient safety across multiple widely-used brands.

Laboratory analysis reveals montelukast demonstrates “significant binding” to multiple brain receptors, suggesting more extensive neurological activity than previously understood.

The inavolisib-based regimen more than doubled progression-free survival in PIK3CA-mutated breast cancers, offering a new standard of care for this challenging patient population.