FDA Issues Draft Guidance on Nusinersen Sodium

The obstacle to generic oligonucleotides may be analytical methodology The U.S. Food and Drug Administration (FDA) has recently released a draft guidance on nusinersen sodium, a drug used to treat spinal muscular atrophy (SMA). The guidance was issued in February Continue reading FDA Issues Draft Guidance on Nusinersen Sodium

Nusinersen API

Nusinersen is an oligonucleotide drug approved by the FDA in 2016 for the treatment of spinal muscular atrophy (SMA). SMA is a rare genetic disease that affects the muscles used for movement, breathing, and swallowing. Nusinersen is the first and Continue reading Nusinersen API