FDA places Atara’s Biothearapeutics’ cancer, autoimmune therapies on hold
The US drug regulator has put a clinical hold on Atara Biotherapeutics’ T-cell therapies for cancer and autoimmune diseases after issues were observed.
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FDA faces Vanda’s ire as it rejects firm’s gastroparesis drug application
Vanda Pharmaceuticals Inc’s gastroparesis drug to treat a serious stomach condition was rejected by the Food and Drug Administration (FDA), which asked for.
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FDA declines approval for Novo Nordisk’s diabetic medicine
Novo Nordisk, has been denied approval for its type 1 diabetic medicine by the USFDA, according to the Danish drugmaker.
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FDA rejects Daiichi, Merck, antibody-drug conjugate application
The USFDA has rejected a Biologics License Application from Daiichi Sankyo and Merck & Co., seeking accelerated approval of patritumab deruxtecan to treat.