FDA advisory committee
FDA Identifies ‘Systemic Bias’ in Amgen’s Late-Stage Lumakras Trial Ahead of Adcomm
Anika Sharma
As an FDA advisory committee prepares to deliberate on the data supporting Amgen’s groundbreaking drug Lumakras, a pre-meeting briefing document ...
FDA panel backs Alnylam’s Onpattro for rare heart condition despite small benefit
Anika Sharma
After facing doubts from the FDA regarding the expansion of its RNA-silencing drug Onpattro into the treatment of transthyretin amyloidosis ...
FDA doubts Onpattro’s benefit in heart disease, Alnylam faces Pfizer hurdle
Anika Sharma
The FDA has raised significant concerns about Alnylam’s attempt to expand the use of Onpattro for the treatment of transthyretin ...
