community-acquired bacterial pneumonia (CABP)

July 7, 2016

NDA for Solithera to Treat Pneumonia Accepted by FDA

The U.S. FDA has accepted two new drug applications (NDAs) from Cempra, which develops antibiotics for bacterial infectious diseases, for Solithera (solithromycin) as a treatment for community-acquired bacterial pneumonia (CABP). The FDA’s ... Read more

June 7, 2016

FDA Approves Supplemental NDA of Allergan’s Teflaro for Children with Pneumonia

The U.S. Food and Drug Administration (FDA) has approved Allergan’s supplemental New Drug Application (sNDA) for Teflaro (ceftaroline fosamil). The approval will result in new indications for pediatric patients ages 2 ... Read more

May 4, 2016May 4, 2016

NDA Submission Complete for Bacterial Pneumonia Treatment of Solithromycin, Cempra Announces

Cempra Inc. announced it has completed submissions to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for its lead product candidate solithromycin for the treatment of ... Read more