Bayer (BAYRY) announced that the U.S. Food and Drug Administration has approved Jivi, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients 7 years of age and older with hemophilia A. The approval is based on data from the Alfa-PROTECT and PROTECT Kids studies, demonstrating Jivi’s safety and efficacy in children aged 7 to under 12 years with severe hemophilia A. This significant milestone reflects Bayer’s ongoing commitment to providing effective treatment options for the hemophilia community. Jivi was first granted approval by the FDA in August 2018 for use in previously treated adults 12 years of age and older with hemophilia A, the company noted.
Confident Investing Starts Here:
- Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions
- Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on BAYRY:
- Trump officials pushback on RFK Jr.’s attack on pesticides, WSJ reports
- UnitedHealth suspends outlook, Under Armour reports Q4 beat; Morning Buzz
- Bayer sees FY25 sales EUR 45B-EUR 47B on currency-adjusted basis
- Bayer confirms mid-term ambition for Crop Science
- Bayer confirms currency-adjusted group outlook for 2025