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The FDA has announced tentative dates for its vaccine-related advisory committee to meet to discuss the much-anticipated full applications for Emergency Use Authorization (EUA) that it expects any day from COVID-19 vaccine manufacturers for children under age six. Read More
Shionogi’s investigative COVID-19 therapy is showing some promise in early laboratory studies, rapidly clearing viral levels and decreasing the period of active shedding, the company reported at the European Congress of Clinical Microbiology and Infectious Diseases. Read More
The FDA has expanded its approval of Gilead Sciences’ Veklury (remdesivir) for pediatric patients 28 days and older weighing at least 6.6 pounds who have tested positive for COVID-19 and are either hospitalized or are at high risk of developing severe COVID-19. Read More
The five members are asking for disclosure regarding the price of the vaccine’s unit, advance payments, donations, liability and indemnification. Read More
Pfizer’s novel antiviral nirmatrelvir plus ritonavir cut the risk of COVID-19-related death or hospitalization by 89 percent relative to placebo, a phase 2/3 study has determined. Read More
Veru has stopped a phase 3 study of its COVID-19 treatment sabizabulin after an interim safety analysis found that the drug overwhelmingly reduced the risk of death by 55 percent in patients with moderate-to-severe disease. Read More
The company is working with regulators in the U.S., Europe and the UK to find ways to gain approval for this drug for the treatment of COVID-19. Read More
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