Bavarian Nordic CEO Says Likely To Sell Imvamune Priority Review Voucher
Danish group believes its smallpox vaccine will get approved, generate a transferable priority review voucher, and replace the current US-licensed replicating smallpox vaccine ACAM2000.
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Keeping Track: Two Goal Date Extensions, Another Herceptin Biosimilar Approval, And A BLA Withdrawal
The latest drug development news and highlights from our US FDA Performance Tracker.
CBER’s novel biologic approvals in 2018 were few, long, and with a low level of innovation. But the center’s work to build regulatory framework for emerging technologies is setting the stage for a different story in 2019.
Danish vaccine specialist's BN-Brachyury has been granted orphan drug designation by the FDA for treating chordoma.