CSL Of Australia Gets U.S. FDA Clearance For Newer Hizentra
This article was originally published in PharmAsia News
Executive SummaryAustralia's CSL received U.S. FDA approval for its Hizentra immune-replacement treatment for patients with genetic disorders
You may also be interested in...
ICER president Steve Pearson is ‘cautiously optimistic’ that net pricing for acute migraine treatments will align with benefits once discounts are factored in.
Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).
CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.