Bavarian Nordic lands breakthrough designation for RSV vaccine; Ucello closes Series A to advance CAR-T therapies
The FDA has granted Bavarian Nordic a Breakthrough Therapy Designation for its vaccine to prevent lower respiratory tract disease caused by respiratory syncytial virus.
The designation will allow Bavarian to work more closely with the FDA for the development and the review of the vaccine. The vaccine is being developed for patients aged 60 and older.
Breakthrough designation is designed to expedite the review of medicines intended to treat serious conditions. The assessment was based off of clinical evidence that showed the candidate might show a significant improvement over an existing therapy.
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