U.S. FDA staff reviewers said Paratek Pharmaceuticals Inc.’s potential new antibiotic is not inferior to current treatments.
Nabriva Therapeutics’ experimental antibiotic lefamulin for CABP met the main goal of a late-stage study.
Antibiotic drugmaker Cempra Inc. will terminate 67 percent of its employees following the U.S. FDA’s rejection of solithromycin, an oral and intravenous drug being evaluated for the treatment of community-acquired bacterial pneumonia (CABP) in adults.
The FDA rejected Cempra Inc.’s antibiotic for community-acquired bacterial pneumonia, citing inadequate data on the drug’s impact on liver and manufacturing issues.
Cempra Inc moved a step closer to approval of its lead antibiotic after the potential blockbuster was successful in a second late-stage trial in patients with a common bacterial infection. Data announced in January had showed that the oral version of the drug was successful in a separate late-stage study in patients with community-acquired bacterial […]