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According to a statement from the FDA, the agency has issued a draft guidance proposing labeling recommendations for breast implant manufacturers that would help patients understand the benefits and risks of implants.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