HealthQuill Complete response letter
The US drug regulator has put a clinical hold on Atara Biotherapeutics’ T-cell therapies for cancer and autoimmune diseases after issues were observed at a third-party manufacturing facility.
Drugs Health Medical Pharma

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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Vanda Pharmaceuticals Inc’s gastroparesis drug to treat a serious stomach condition was rejected by the Food and Drug Administration (FDA), which asked for additional studies, according to a company statement.
Drugs Health Pharma

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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Novo Nordisk, has been denied approval for its type 1 diabetic medicine by the USFDA, according to the Danish drugmaker.
Drugs Health Pharma

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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The USFDA has rejected a Biologics License Application from Daiichi Sankyo and Merck & Co., seeking accelerated approval of patritumab deruxtecan to treat a type of lung cancer.
Drugs Health Pharma

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.

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