PM01183 ... A Look Back at FDA News in August 2018 .

Danielle Ternyila // Published Online : Tue September 4, 2018 .

In August 2018, the FDA approved several drugs and treatment regimens. There were also a number of breakthrough therapy designations granted this month, as well as a new orphan drug designation. One drug was granted a priority review, while several new drug applications (NDAs) and supplemental biologics license applications (sBLAs) were submitted.

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Link : Lurbinectedin Granted Orphan Drug Designation from FDA for SCLC 

An orphan drug designation was granted by the FDA for lurbinectedin. PharmaMar, the manufacturer of the drug, made the announcement on August 6. Data from a phase II multicenter basket trial support this treatment option for patients with SCLC.

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