Articles related to FDA

Suzetrigine, a newly approved NaV1.8 inhibitor, offers a promising non-opioid alternative for managing moderate-to-severe acute pain, backed by robust clinical trial data.

The Trop-2-directed antibody-drug conjugate demonstrated a 2.3-month improvement in progression-free survival compared to standard chemotherapy options, offering a new treatment pathway for patients with limited options.

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.