October 28, 2019
Article
According to a statement from the FDA, the agency has issued a draft guidance proposing labeling recommendations for breast implant manufacturers that would help patients understand the benefits and risks of implants.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.
July 05, 2019
Article
Aiwu Ruth He, MD, PhD, discusses treatment options in a Targeted Oncology live case-based peer perspectives discussion based on 2 case studies of patients with hepatocellular carcinoma.
May 30, 2019
Article
Copanlisib has been granted with a breakthrough therapy designation from the FDA for the treatment of adult patients with relapsed marginal zone lymphoma who have received at least 2 prior therapies.
April 05, 2019
Article
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.
March 08, 2019
Article
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.