When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when ...
An independent research firm is reviewing data on Amgen’s Tavneos as the company prepares for a hearing with the FDA which ...
ImmunityBio's shares rise after the FDA accepts a filing to expand Anktiva's use in bladder cancer, with a decision due by January 2027.
Sanofi SNY announced that the FDA has accepted a regulatory filing seeking to expand the use of its type 1 diabetes (T1D) drug, Tzield (teplizumab), in individuals aged one year and older. The agency ...
A Kura Oncology and Kyowa Kirin-partnered drug vying to become the first FDA-approved treatment for cases of acute myeloid leukemia (AML) carrying a particular genetic signature will have its ...
MIRA trial data demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo (p < 0.001) at week 12. VELA-1 met all primary and key secondary endpoints with statistical significance ...
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