12:49 PM
 | 
Oct 05, 2018
 |  BC Week In Review  |  Clinical News  |  Regulatory

Insmed antibiotic is first approved via FDA's LPAD pathway

FDA granted the first expedited approval of an antibiotic under its limited population pathway for antibacterial and antifungal drugs Sept. 28. The agency granted accelerated approval to Arikayce amikacin liposome inhalation suspension from Insmed Inc. (NASDAQ:INSM) to treat lung disease caused by Mycobacterium avium complex (MAC).

Arikayce is approved as part of a combination antibacterial drug regimen for...

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