Health ❯ Healthcare ❯ Regulatory Affairs ❯ FDA

Drug Approval Process

FDA Removes Broad Boxed Warnings From Many Menopause Hormone Therapies

The agency acted after a fresh evidence review concluded risks vary by patient characteristics.

FDA Rejects Biohaven’s Vyglxia for Spinocerebellar Ataxia

FDA Approves Lynkuet, a Nonhormonal Pill for Menopausal Hot Flashes

FDA Expands Revumenib Approval to NPM1-Mutant Relapsed/Refractory AML in Patients 1 and Older