US regulator allows GSK’s endometrial cancer therapy for expanded use
The US drug regulator has granted permission for expanded use of British pharmaceutical company, GSK Plc’s endometrial cancer drug.
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Adaptimmune’s therapy to treat rare form of cancer gets USFDA nod
UK-based biopharmaceutical company, Adaptimmune Therapeutics Plc, got FDA approval for its cell therapy for treating a rare form of cancer.
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USFDA gives nod to Janssen Research’s blood cancer therapy
The US Food and Drug Administration has approved the Darzalex Faspro combination drug therapy of Janssen Research and Development for treating blood cancer.
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FDA issues warning over weight-loss drug overdose, dosing errors
Overdose of weight-loss drugs and dosing errors by patients and healthcare providers have led to adverse events, including hospitalisation, the USFDA warned.
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Novo Nordisk’s Wegovy gets UK regulator nod to treat heart risks
The UK’s Medicines and Healthcare products Regulatory Agency has approved Novo Nordisk’s weight-loss drug to cut the risk of obesity and adults suffering.
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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.
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USFDA issues new draft guidance for trials to expand race, ethnicity
In a bid to include an under-represented population, the US drug regulator has advised healthcare firms to improve racial, ethnic and other diversity.
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FDA gives nod to Bristol Myer’s colorectal cancer therapy
The US Food and Drug Administration has greenlighted Bristol Myers Squibb’s combination therapy to treat metastatic colorectal cancer in patients with a mutated.
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FDA gives nod for AstraZeneca’s Imfinzi to treat endometrial cancer
The US Food and Drug Administration has approved AstraZeneca’s combination therapy, Imfinzi, for adult patients with endometrial cancer, according to a company statement.