U.S. health regulators are expected to authorize a booster shot of Pfizer/BioNTech’s COVID-19 vaccine for children aged 5 to 11 as soon as May 17, the New York Times reported on May 16, citing people familiar with the matter.
Abbott agreed to enter into a consent decree with the U.S. Food and Drug Administration related to the company’s Sturgis, Mich., infant formula plant. The decree is an agreement between the FDA and Abbott on the steps necessary to resume production and maintain the facility. This does not affect any other Abbott plant or operation. The decree is subject to court approval.
The U.S. Food and Drug Administration will make an announcement regarding imported infant formula as soon as later on May 16, the agency’s chief told NBC News in an interview as regulators and lawmakers seek to address ongoing supply shortages.
Eli Lilly scored another win against diabetes as the company’s once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide won approval under Priority Review from the U.S. Food and Drug Administration.
As the fairness of orphan drug exclusivities is debated in Congress, the U.S. Food and Drug Administration granted Orphan Drug designations to Editas Medicine and Neurocrine Biosciences.
Researchers at Yale University published research in Molecular Biology and Evolution describing a new molecular analysis approach to quantify DNA changes that contribute to cancer growth.
One day after BridgeBio Pharma struck a nearly $1 billion oncology pact with Bristol Myers Squibb, the California-based company announced plans to sell a priority review voucher received in February.
The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.
Moderna Inc. has made all necessary submissions required by the U.S. Food and Drug Administration for emergency use authorization of the company’s COVID-19 vaccine in adolescents and children.
The U.S. Food and Drug Administration granted approval for the commercialization of Eli Lilly and Company and Incyte Corporation’s Olumiant (baricitinib), setting a precedent for COVID-19 treatments.