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Drug Approval

Leucovorin Wegovy Zepbound Chronic Graft-Versus-Host Disease FDA Regulations Iloprost Chronic Obstructive Pulmonary Disease Alzheimer's Disease Obstructive Sleep Apnea Lupus Nephritis Tavneos FDA FDA Decisions Mifepristone FDA Advisory Committee Alzheimer's Treatment Novel Medicine

4 ARTICLES

4w ago

EMA Committee Recommends Revoking Tavneos Authorization

The committee found the pivotal ADVOCATE trial breached good clinical practice and persistent reports of serious liver injury mean the drug’s benefits can no longer be shown to outweigh its risks.

23 ARTICLES

4mo ago

FDA Approves Leucovorin for Ultra-Rare FOLR1 Folate Disorder, Declines Autism Indication

9 ARTICLES

9mo ago

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

3 ARTICLES

9mo ago

FDA Clears Second Generic Mifepristone as White House Cites Legal Duty

6 ARTICLES

10mo ago

FDA Backs Leucovorin for Cerebral Folate Deficiency as White House Promotes Autism Use