Incyte announced results from a Phase 3 trial of ruxolitinib compared to best available therapy in patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.
The FDA has accepted for review an additional sNDA for the proposed expanded label for Lymphoseek (technetium 99m tilmanocept; Navidea) Injection to support broader and more flexible use in imaging and lymphatic mapping procedure.
The FDA has issued a Complete Response Letter for the New Drug Application (NDA) of empagliflozin (Boehringer Ingelheim and Eli Lilly and Company) for the reduction of blood glucose levels in adults with type 2 diabetes.
Forest Laboratories has submitted a NDA for a fixed-dose combination of memantine HCl extended release and donepezil HCl for the treatment of moderate to severe dementia related to Alzheimer's disease.
Enanta announced results from the PEARL-III trial studying ABT-450 for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection using a three direct-acting antiviral regimen.
Boehringer Ingelheim has announced positive results from several Phase 3 studies on the once-daily tiotropium Respimat inhaler as an add-on treatment for asthma.
Genervon was granted an orphan drug designation by the FDA for its bio-drug GM604 (also known as GM6) for the treatment of amyotrophic lateral sclerosis (ALS).
Sunovion and Takeda announced results from a new study evaluating the efficacy and safety of lurasidone (Latuda; Sunovion) in the maintenance treatment of adults with schizophrenia.
The FDA has granted Orphan Drug designation to Pracinostat (MEI Pharma) for the treatment of acute myeloid leukemia (AML).
Pacira Pharmaceuticals announced that the Phase 3 trial assessing the safety and efficacy of Exparel (bupivacaine liposome injectable suspension) in femoral nerve block for total knee arthroplasty met its primary efficacy endpoint.