Postmarketing Trial For Horizon Thyroid Eye Drug Tepezza To Be Larger Than Expected
Horizon CEO says safety trial will be conducted in a larger patient population following discussions during the US FDA advisory committee meeting.
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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).
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.
The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.