Invivyd has submitted a Citizen Petition urging the FDA to reevaluate COVID-19 prevention strategies, emphasizing the need for monoclonal antibodies alongside vaccines in the endemic phase of the virus.
Invivyd has signed a $30 million term loan facility with Silicon Valley Bank, providing non-dilutive capital access contingent on meeting specific milestones and conditions.
The FDA has rejected Invivyd's application to expand Pemgarda's emergency use authorization for treating mild to moderate COVID-19 in immunocompromised patients without alternative treatment options.
Iterum Therapeutics receives FDA approval for ORLYNVAH™, marking the first branded uncomplicated UTI treatment to enter the U.S. market in over 25 years and the first oral penem antibiotic approved in the country.
Invivyd's VYD2311 demonstrates positive safety and pharmacokinetic profiles in an ongoing Phase 1/2 clinical trial, with complete enrollment and dosing.
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