News

Based on the data contained in the NDA for Saxenda, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the

The Committee’s recommendation will be considered by the FDA in its review of the company’s Biologics License Application (BLA) for Natpara, which has a Prescription Drug User Fee

Tecemotide was being assessed in the Phase III START2, START and INSPIRE trials to treat unresectable, locally advanced Stage III NSCLC. In 2007, the company received the exclusive

The new joint venture (JV) will be known as TIPR-HUYA Advancing Innovative Medicines (TIPR-HUYA-AIM). Under the deal, the two firms will share equally in decision-making regarding product development

Preeclampsia is one of the most common complications of pregnancy and it leads to increased risk of maternal mortality, perinatal fetal mortality, fetal pre-maturity, or even the need

SYN-005 is being developed through Synthetic Biologics’ exclusive channel collaboration with Intrexon (XON) and academic researchers at the University of Texas at Austin to target and neutralize the

Made from allogeneic human Umbilical Cord Blood-derived Mesenchymal Stem Cells (hUCB-MSCs), PNEUMOSTEM is expected to have effect on regenerating the lung tissue and improving inflammatory responses in premature

Hyqvia is a combination of Immune Globulin Infusion 10% (Human) (IG 10%) and Recombinant Human Hyaluronidase developed by Halozyme. The first subcutaneous immune globulin (IG) treatment is approved

The approval allows the tablets for use in chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27