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USFDA issues new draft guidance for trials to expand race, ethnicity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.
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US audit finds gaps in FDA’s procedures during infant formula crisis
The US drug regulator, FDA, did not have an organizational structure or assigned responsibilities to handle whistleblower complaints “efficiently and effectively” and took.
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Israel’s Teva Pharmaceuticals sue Corcept, Optime over drug monoploy
Israel’s Teva Pharmaceuticals has sued US-based Corcept Therapeutics and Optime Care Inc., a specialty pharma, for monopolising the market for a drug used to.
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FDA advisers reject psychedelic party drug MDMA to treat PSTD in adults
The advisory committee of the US Food and Drug Administration has rejected a therapy using party drug MDMA, or ecstasy or molly to.
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US drug regulator clears Amgen’s biosimilar to treat rare blood disorder
The US drug regulator has approved Amen’s biosimilar, Bkemv, to treat rare blood disorders, according to a statement from the Food and Drug.