The company said that the marketing authorization decision could come early next year.
Tag Archive for: bone marrow cancer
GSK Plc said on Friday the U.S. Food and Drug Administration (FDA) has extended the review period by three months for a drug the British drugmaker gained through its $1.9 billion buyout of Sierra Oncology last year.
Nelarabine Injection ensures access to a lifesaving treatment that historically has been in shortage.
The drug will be sold under the brand Rezlidhia and indicated for treating acute myeloid leukemia in patients with a susceptible genetic mutation.