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FDA Class II Recall Targets Generic Vyvanse After Dissolution Failures

Testing found some capsules do not dissolve properly, risking reduced therapeutic effect.

FDA Removes Broad Boxed Warnings From Many Menopause Hormone Therapies

FDA to Remove Most Boxed Warnings From Menopause Hormone Therapies

FDA Rejects Biohaven’s Vyglxia for Spinocerebellar Ataxia

FDA Class II Recall Issued for 141,984 Bottles of Generic Atorvastatin Over Dissolution Failures

FDA Setback Puts uniQure’s Huntington’s Gene Therapy Filing in Doubt

FDA Approves Lynkuet, a Nonhormonal Pill for Menopausal Hot Flashes

FDA Lists Class II Recall of 141,984 Bottles of Generic Atorvastatin

Neutrogena Recalls One Lot of Makeup Remover Wipes in Four States After FDA Detects Bacteria

FDA Approves Lynkuet, a Nonhormonal Pill for Menopausal Hot Flashes

Ascend Recalls 141,984 Bottles of Generic Atorvastatin Over Dissolution Failures

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

FDA Reapproves GSK’s Blenrep for Multiple Myeloma in Narrow Combination Use

Kenvue Asks FDA to Reject Autism Warning on Tylenol in Pregnancy

FDA Names First 9 Drugs for ‘National Priority’ Fast-Track Reviews, Targeting 1–2-Month Decisions