We use cookies to help provide you with the best possible online experience. Please read our Privacy Policy for information about which cookies we use and what information we collect on our site. By continuing to use this site, you agree that we may store and access cookies on your device.
The FDA has issued a complete response letter to Mallinckrodt’s jaundice drug stannsoporfin. Mallinckrodt plans to talk to the FDA in the coming months before deciding the fate of a drug it acquired in an $80 million buyout last year.
An FDA advisory committee voted on Thursday to recommend approval of Paratek’s new antibiotic, omadacycline, for the treatment of acute bacterial skin infections and community-acquired bacterial pneumonia (CABP).
Paratek Pharmaceuticals’ first drug, and the first in a new class of broad-spectrum antibiotics called aminomethylcyclines, has shown to be noninferior to current regimens for bacterial pneumonia and skin infections, FDA reviewers wrote ahead of an Aug. 8