HealthQuill USFDA
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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In a bid to include an under-represented population, the US drug regulator has advised healthcare firms to improve racial, ethnic and other diversity factors during clinical trials.
Drugs Health Pharma

USFDA issues new draft guidance for trials to expand race, ethnicity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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The US Food and Drug Administration has greenlighted Bristol Myers Squibb’s combination therapy to treat metastatic colorectal cancer in patients with a mutated gene.
Drugs Health Pharma

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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The US Food and Drug Administration has approved AstraZeneca’s combination therapy, Imfinzi, for adult patients with endometrial cancer, according to a company statement.
Drugs Health Pharma

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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The US drug regulator, FDA, did not have an organizational structure or assigned responsibilities to handle whistleblower complaints “efficiently and effectively” and took more than 15 months to address a February 2021 Abbott facility whistleblower complaint, according to a federal audit.
Drugs Health Pharma

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 has sued US-based Corcept Therapeutics and Optime Care Inc., a specialty pharma, for monopolising the market for a drug used to treat a rare hormonal disorder.
Drugs Medical Pharma

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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The advisory committee of the US Food and Drug Administration has rejected a therapy using party drug MDMA, or ecstasy or molly to treat post-traumatic stress disorder.
Drugs Health Pharma

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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The US drug regulator has approved Amen’s biosimilar, Bkemv, to treat rare blood disorders, according to a statement from the Food and Drug Administration.
Drugs Health Pharma

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.

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The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA refused approval for a once-weekly jab to control blood sugar levels in people with type 1 diabetes, with seven members voting for and four against.
Drugs Health Pharma

FDA panel rejects Novo Nordisk’s weekly jab to treat type 1 diabetes

The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA refused approval for a once-weekly jab to control blood sugar levels in people.

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The US Food and Drug Administration has cleared Amgen’s drug to treat adult patients in the extensive stages of small cell lung cancer (ES-SCLC) with disease progression on or after chemotherapy.
Drugs Health Pharma

USFDA gives nod to Amgen’s therapy for treating small cell lung cancer 

HQ Team May 17, 2024: The US Food and Drug Administration has cleared Amgen’s drug to treat adult patients in the extensive stages.

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