Keeping Track Of Breakthrough Therapy Designations: Depression, Headaches, Hepatitis
The latest developments in one of the US FDA's favorite pathways.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Private Company Edition: BIO comments suggest definitions of personal data expand the scope of foreign investments in biotech companies that must be reviewed by the Committee on Foreign Investment in the United States (CFIUS). Also, NeuroRx’s $95m deal leads recent private financings.
Gene therapy and lambda interferon products are highlighted in the new Review Pathways section of the US FDA Performance Tracker, which keeps track of breakthrough therapy (BTD), regenerative medicine advanced therapy (RMAT), qualified infectious disease product (QIDP) designations and biosimilar submissions.