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After AdComm rejection, Mallinckrodt’s stannsoporfin gets stiff-armed at FDA fiercebiotech
August 23, 2018
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.
Paratek’s omadacycline sails through AdComm en route to October nod fiercebiotech
August 10, 2018
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).
FDA notes Paratek antibiotic’s noninferiority as it heads to AdComm vote fiercebiotech
August 08, 2018
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