FDA aproves Elelyso (Pfizer) for Type 1 Gaucher Disease
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Takeda announced that the FDA has approved the supplemental Biologics License Application (sBLA) for the expanded use of Takhzyro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients 2 to <12 years of age.
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.