The FDA accepted Indivior’s application for its new once-monthly injectable schizophrenia treatment.
The U.S. Food and Drug Administration proposed creating a new fast track to market for certain medical devices and a potential reduction in the amount of safety data required for approval.
Amgen Inc. said a final analysis of late-stage trial data showed that its Kyprolis combined with two other drugs helped blood cancer patients live longer.
Nearly a third of patients with an advanced form of a fast-progressing leukemia who carry a specific genetic mutation experienced a complete or near complete response to an experimental Agios Pharmaceuticals drug, according to data from an early-stage trial.
The U.S. Food and Drug Administration approved Sanofi SA’s Admelog as the first follow-on biologic version of Eli Lilly and Co.’s fast-acting insulin Humalog.
At the American Society of Hematology meeting, Genentech revealed long-term data showing the drug maintains its efficacy over an extended period of time.
Summit, NJ-based Celgene and Cambridge, Mass.-based bluebird bio released updated data from an ongoing Phase I clinical trial of bb2121 at the American Society of Hematology (ASH) Annual Meeting in Atlanta.
Scientists have for the first time fixed a protein defect that causes Huntington’s disease by injecting a drug from Ionis Pharmaceuticals into the spine, offering new hope for patients with the devastating genetic disease.
The DUO study showed statistically significant PFS improvement for duvelisib versus standard of care treatment ofatumumab.