Cempra

Cempra, Melinta merge to form commercial-stage anti-infectives company

Wednesday, August 9, 2017

Cempra, Inc., a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for acute care and community settings to meet critical medical needs in the treatment of infectious diseases, and Melinta Therapeutics, a privately held company focused on discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, have announced that the companies have entered into a definitive agreement under which Melinta will merge with a subsidiary of Cempra. The merger is expected to create a company committed to discovering, developing and commercializing important anti-infective therapies for patients and physicians in areas of significant unmet need.

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Cempra receives complete response letter from FDA for solithromycin NDAs

Tuesday, January 3, 2017

Cempra, a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, has announced that the company has received a Complete Response Letter (CRL) from the FDA relating to the company’s new drug applications (NDAs) for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

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Cempra outlines steps for regulatory approval of solithromycin

Monday, June 17, 2013

Cempra, a clinical-stage pharmaceutical company developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infections, has described the steps expected for regulatory approval for solithromycin for community-acquired bacterial pneumonia (CABP).  This path is a result of a dialogue and end-of-phase II meeting with the FDA.

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