FDA Approval

Published: Oct 09, 2023 - FDA Cites Insufficient Evidence of Clinical Meaningfulness - - No Clinical Safety, Study Conduct, Drug Quality or Manufacturing…
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced that the U.S. Food and Drug Administration (FDA) approved AMVUTTRA(tm) (vutrisiran…
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved both VYNDAQEL(R) (tafamidis meglumine) and VYNDAMAX(tm) (tafamidis) for…
The FDA today granted Alnylam Pharmaceuticals approval for a first-in-class small interfering ribonucleic acid (siRNA) treatment-the first therapy indicated for…
The US Food and Drug Administration (FDA) has approved inotersen (Tegsedi, Akcea Therapeutics and Ionis Pharmaceuticals) for the treatment of polyneuropathy (PN) in…
A new hereditary ATTR (hATTR) amyloidosis treatment, inotersen, an investigational antisense drug, may not be far from a US Food and Drug Administration (FDA)…
The FDA announced that it has approved patisiran infusion for the treatment of patients with peripheral nerve disease caused by hereditary transthyretin-mediated…