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After AdComm rejection, Mallinckrodt’s stannsoporfin gets stiff-armed at FDA
fiercebiotech
August 23, 2018The 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, 2018An 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, 2018Paratek 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
Pharma Sources Insight January 2025
