Antibiotic Spring? Regulatory Incentives Spur Activity – And Maybe Medical Advances
Regulatory incentives have been successful at attracting developers to antibiotic R&D, but significant medical advances have stubbornly remained rare. Now the pipeline has produced the first novel antibiotic to receive breakthrough status from US FDA and some Phase III trials are raising the efficacy bar to superiority.
You may also be interested in...
Advisory committee will review applications for cUTI indication, which looks good, and the BSI indication, which looks fraught.
It's too early to say whether program is working, FDA tell Congress; agency has awarded 147 QIDP designations, but none of 12 approved antibacterals have new mechanism of action.
Keeping Track: A Burst of CRLs and BTDs, A Busy Week Of Submissions And Another Approval For Soliris
The latest drug development news and highlights from our US FDA Performance Tracker.