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The FDA cited over-the-counter drugmaker OraLabs for laboratory control lapses and other failures observed during an inspection of its Parker, Colorado facility. Read More
Sanofi has agreed to pay $3.7 billion for San Francisco-based Principia Biopharma, giving the French drugmaker full control of a potential multiple sclerosis drug. Read More
The FDA is willing to consider a range of clinical trial designs and various endpoints for new drugs or biologics intended to treat acute myeloid leukemia (AML), according to a new draft guidance. Read More
CanSino Biologics’ experimental COVID-19 vaccine has entered a late-stage trial in Russia, the company leading the study announced yesterday. Read More
Vancouver, Wash.-based drugmaker CytoDyn is seeking an Emergency Use Authorization (EUA) from the FDA for its HIV treatment leronlimab for the treatment of mild-to-moderate COVID-19 patients. Read More
Sinopharm’s COVID-19 vaccine generated antibodies at levels on par with some of its competitors, according to early trial data released by scientists connected with the company and other China-based research institutes. Read More