FDA accepts sNDA for review of Myfembree in uterine fibroid treatment
June 13th 2022The FDA recently announced the acceptance of a supplemental New Drug Application for relugolix 40 mg, estradiol 1 mg, and norethindrone acetate .5 mg in the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
FDA grants Priority Review to Dupixent® for kids 6 months to 5 years
February 10th 2022The US Food and Drug Administration has given Priority Review to the supplemental Biologics License Application for the use of Dupixent® as an add-on maintenance treatment for moderate-to-severe dermatitis in children aged 6 months to 5 years.