
- The U.S. Food and Drug Administration (FDA) has approved Bluebird bio’s (NASDAQ:BLUE) lead asset ZYNTEGLO (betibeglogene autotemcel) to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. Bluebird shares traded in a range of $6.13 to $8.18 on a day volume of 27.26 million shares, closed regular trading session at $6.78. The company shares are currently trading at $7.25, up 6.93 percent in the after-hours trading session.
- Samsung Bioepis and Organon (NYSE:OGN) announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab). HADLIMA will be available in pre-filled syringe and autoinjector options, and the autoinjector was specifically designed with the patient in mind. Organon shares traded in a range of $30.61 to $31.13 on a day volume of 1.09 million shares, closed regular trading session at $30.87.