After the July 4 holiday, the U.S. Food and Drug Administration has several items on the regulatory agency’s immediate calendar, including a couple target action dates and an advisory committee hearing.
The U.S. Food and Drug Administration approved Chiesi Global Rare Diseases’ Ferriprox (deferiprone) for the treatment of transfusional iron overload caused by sickle cell disease or other anemias in adults and children ages 3 years and older.
Shares of FibroGen were down after the company unsuccessfully attempted to express confidence in the benefit/risk profile of its anemia drug roxadustat.
The U.S. Food and Drug Administration decided to put together an advisory committee meeting of outside experts to review a New Drug Application (NDA) for FibroGen and partner AstraZeneca’s investigational anemia therapy roxadustat.
FibroGen Provides More Support for Roxadustat in Anemia Associated with Kidney Disease Published: Oct. 26, 2020 By Mark Terry BioSpace FibroGen presented data from two pooled analyses from its roxadustat global […]
Cambridge, Massachusetts-based Akebia Therapeutics announced topline results for PRO2TECT, the second of two Phase III cardiovascular outcomes programs evaluating the company’s vadadustat for treatment of anemia caused by chronic kidney disease in adults not on dialysis.
Pharmacosmos Therapeutics Inc. was established as a newly formed specialty pharmaceutical company dedicated to commercializing Monoferric for iron deficiency anemia (IDA) patients in the United States.
Nearly 1.6 billion people worldwide suffer from anemia, and for the first time new research points to how resistance emerges to the drug dexamethasone used to treat the devastating inherited form of anemia known as Diamond Blackfan anemia (DBA).
Bristol-Myers Squibb announced the completed acquisition of Celgene following the receipt of regulatory approval from all government authorities required by the merger agreement and, as announced in April 2019, approval by the companies’ stockholders.
The U.S. FDA approved Celgene and Acceleron Pharma’s Reblozyl for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
