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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Keeping Track: Oxbryta Approval Headlines Pre-Thanksgiving Week Of News
The latest drug development news and highlights from our US FDA Performance Tracker.
Finance Watch: BIO Says Proposed Foreign Investment Regulations Will Lower Investment In US Biotech
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.
Mustang Bio Joins RMAT List; Eiger Brings Home Its 4th BTD
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.