FDA rejects Advancis' NDA on strep therapy

The FDA has rejected Advancis Pharmaceuticals' NDA for a new strep throat therapy, saying it cannot be approved in its current form. In a letter, the FDA explained that it had questions about how Advancis plans to scale up its manufacturing process. Advancis, which says it was surprised by the letter, plans to meet with the agency to discuss its concerns. Advancis' trial on Amoxicillin Pulsys failed in 2005 but was successfully completed last summer.

- read the report on the FDA's action from the Washington Business Journal

Suggested Articles

The clamor for more transparency from the leading pandemic vaccine contenders has been getting louder.

The role gives one of the driving forces behind Bristol Myers Squibb’s $74 billion takeover of Celgene the chance to help build biotechs.

The appointment gives Sino-American biotech Brii the experience of a man who helped Gilead launch eight drugs in China in quick succession.