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Articles

FDA Considers New Warning and Label Recommendations for Breast Implants

October 28, 2019

According to a statement from the FDA, the agency has issued a draft guidance proposing labeling recommendations for breast implant manufacturers that would help patients understand the benefits and risks of implants. The labeling recommendations would include the addition of a boxed warning.

NDA Review Period Extended by FDA for Quizartinib in FLT3-ITD+ AML

April 05, 2019

The review period on the new drug application for quizartinib as a treatment for adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia has been extended by the FDA by 3 months. This provides the FDA with additional time to review more data supplied by Daiichi Sankyo, the manufacturer of the FLT3 inhibitor.

Atezolizumab/Nab-Paclitaxel Approved by the FDA for PD-L1+ TNBC

March 08, 2019

An accelerated approval has been granted by the FDA for the combination of atezolizumab and nab-paclitaxel as a frontline treatment for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.