AbbVie and Neurocrine submitted an NDA to FDA for elagolix for bleeding associated with uterine fibroids, leading in what is expected to be a competitive market.

Despite many improvements in the last 25 years, there continue to be serious unmet medical needs in the area of reproductive health. ObsEva SA, a clinical-stage biopharmaceutical company based in Geneva, Switzerland, aims to address some of those needs with novel oral drugs for three highly prevalent reproductive health-related challenges: endometriosis, pre-term labor, and repeated implantation failure in women undergoing in vitro fertilization.

The US FDA has given the go-ahead for marketing of ViiV healthcare’s novel HIV drug just as the EMA removes the accelerated assessment status from its application there.