Merck, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
Symbiomix Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved its lead product Solosec™ (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women.
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, announced that the European Commission(EC) has approved Xermelo® (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
The US Food and Drug Administration(FDA) has approved Amgen’s Mvasi (bevacizumab-awwb) as a biosimilar to Roche/Genentech’s Avastin (bevacizumab) for the treatment of multiple types of cancer, making it the first biosimilar approved in the country for the treatment of cancer.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental New Drug Application (sNDA) for the use of TRISENOX® (arsenic trioxide) injection in combination with all-trans retinoic acid (ATRA) for induction of remission and consolidation in patients with newly diagnosed low or intermediate risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Sanofi announced that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog. Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus.
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