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The U.S. Food and Drug Administration (FDA) has ordered Pfizer and Moderna to expand their warning labels on COVID-19 ...
The FDA has called for Pfizer and Moderna to update the safety information on their mRNA COVID-19 vaccines to include warnings on the incidence of myocarditis and pericarditis, according to two ...
The company said the discontinuation was due to several reasons,” Reuters news service reported, “including limited interest ...
Bayer’s Jivi is a factor VIII replacement therapy that has been engineered with a compound that allows for less frequent dosing. It is now indicated for patients 7 years of age and older.
The FDA has extended its approval of Jivi to cover the therapy's use in children with hemophilia A ages 7 years and older.
Treatment options for children with hemophilia A have expanded with the FDA approval of Bayer's Jivi antihemophilic factor (recombinant), PEGylated-aucl for the treatment of pediatric patients between ...
The approval in previously treated pediatric patients was based on data from the Alfa-PROTECT and PROTECT Kids studies.
The U.S. Food and Drug Administration (FDA) on Wednesday approved Merck & Co. Inc.’s (NYSE:MRK) Welireg (belzutifan) for adult and pediatric patients 12 years and older with locally advanced ...
Healthcare & Pharmaceuticalscategory· October 11, 2024 US FDA approves Pfizer's drug for rare bleeding ... types of a rare bleeding disorder called hemophilia, the company said on Friday.
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