The company will present data at the oncology meeting showing the drug’s significant survival benefit in patients with advanced renal cancer and recurrent, persistent and metastatic cervical cancer.
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The recommendation follows a review by EMA’s human medicines committee (CHMP) that concluded the benefits of the drug did not outweigh risks, according to the regulator.
Its establishment of a mainland China unit comes as its revenue growth slows sharply due to waning global demand for its COVID-19 vaccine, the U.S. company’s only approved product.
The amendment cuts the number of COVID-19 vaccines that the EU must buy and pushes the delivery deadline to 2026.
The FDA nod “represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet. It did not elaborate on the aims of the study, saying only that it was not recruiting yet and more details would be available soon.
Today AstraZeneca announced that a combination of its cancer drugs Imfinzi and Lynparza when added to platinum-based chemotherapy showed positive results in a late-stage trial in patients with advanced or recurrent endometrial cancer.
The Massachusetts-based biopharma became the second company this week to drop its amyotrophic lateral sclerosis hopeful after it failed to elicit significant improvement compared with placebo.
The AI drug discovery company’s reorganization will include laying off around 180 employees and dropping its atopic dermatitis candidate BEN-2293 in an effort to save nearly $56 million.
The U.S. Food and Drug Administration on Thursday granted a full approval to Pfizer’s Paxlovid, an oral antiviral COVID-19 treatment for adults at high risk of progression to severe disease.
The investigational kinase inhibitor failed to improve overall survival in the SAPPHIRE study of patients with non-squamous non-small cell lung cancer, causing Mirati to discontinue its development.