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The U.S. Food and Drug Administration approved AbbVie’s Skyrizi (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts 30 percent of patients with psoriasis.
Three U.S. studies show that a third dose of an mRNA vaccine is key to fighting the Omicron coronavirus variant, providing 90% protection against hospitalization due to COVID-19, the U.S. Centers for Disease Control and Prevention (CDC) said on January 21.
The U.S. FDA on January 21 expanded the health regulator’s approval for the use of Gilead Sciences’ antiviral drug remdesivir to treat non-hospitalized patients 12 years and older for the treatment of mild-to-moderate COVID-19 disease with high risk of hospitalization.
Rick Pazdur, director of the U.S. Food and Drug Administration’s Oncology Center of Excellence and longtime defender of the agency’s accelerated approval program, acknowledged that some changes are likely needed to the process to ensure timely receipt of confirmatory trial data.
A judge in Texas ruled on January 21 that President Joe Biden could not require federal employees to be vaccinated against the coronavirus and blocked the U.S. government from disciplining employees who failed to comply.
The Biotechnology Innovation Organization (BIO) provides a glimpse of economic development in the biosciences ecosystem at the state and regional levels. The report, which was developed in partnership with the Council of State Bioscience Associations (CSBA), was released as an industry analysis in the wake of the COVID-19 pandemic and its impact on the overall economy.
In very young children, the Omicron variant of the coronavirus causes less severe disease than the Delta variant, according to a new study. In other research, new findings add to evidence that people with a certain version of a gene are less likely to develop severe COVID-19.
Sorrento Therapeutics announced that the company’s COVID-19 treatment Covishield (STI-9167) shows significant progress in neutralizing Omicron and Omicron variants of SARS-COV-2.
GlaxoSmithKline and U.S. partner Vir Biotechnology will boost production of their antibody-based COVID-19 treatment by adding a second manufacturing plant to help meet soaring demand in the United States.
Pfizer Inc. said on January 21 the U.S. health regulator declined to approve somatrogon as a treatment for growth hormone deficiency in children that the company developed with partner Opko Health Inc.