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The FDA has turned down a new drug application from Blueprint Medicines for Ayvakit (avapritinib) for treatment of adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST). Read More
FDA drug approvals were down 16 percent in 2019 compared with 2018, a reduction that predates the COVID-19 outbreak, according to data and analytics firm GlobalData. Read More
Moderna previously received fast-track designations for three of its messenger RNA vaccine programs, including its investigational Zika vaccine. Read More
The FDA has granted Moderna’s COVID-19 vaccine candidate a fast-track designation, making it the first potential vaccine to receive the agency’s expedited review status. Read More