- The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ (NASDAQ:SPPI) lead asset ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia. Spectrum Pharmaceuticals shares traded as high as 3.17 percent, in a range of $1.21 to $1.30 on day volume of 6.8 million shares versus three months average volume of 2.72 million shares, closed regular trading session at $1.30. The company shares traded at $1.44, up 11.2 percent in the after-hours trading session.
- The U.S. Food and Drug Administration (FDA) has accepted for review Pfizer’s (NYSE:PFE) New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. The regulatory agency is expected to make a decision in the second-quarter 2023. Additionally, The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for ritlecitinib in the alopecia areata patient population with a decision anticipated in the fourth-quarter 2023. Pfizer shares traded as high as 1.93 percent, in a range of $47.11 to $47.99 on day volume of 17.5 million shares, closed regular trading session at $47.84.
