European Commission rejects Uplyso( Pfizer/Protalix) for Gaucher Disease
Related news and insights
MaaT Pharma reported that the FDA has responded to the Company’s Investigational New Drug (IND) Application to initiate in the U.S. an open-label, single arm Phase III pivotal clinical trial evaluating the safety and efficacy of MaaT 013 in patients with steroid-resistant acute Graft-versus-Host Disease (aGvHD).
Merck Inc., known as MSD outside of the United States and Canada, announced that the Phase III NRG-GY018 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel) met its primary endpoint of progression-free survival (PFS) for the treatment of patients with stage III-IV or recurrent endometrial carcinoma regardless of mismatch repair status.
Gilead Sciences, Inc. has announced the FDA has approved Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.