Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for evolocumab for the treatment of high cholesterol.
The Food and Drug Administration (FDA) has granted Fast Track status for Pfizer's investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090).
A recent study has demonstrated potential for lexaptepid pegol as the first treatment for anemia of inflammation, the most common form of anemia.
The Food and Drug Administration (FDA) has granted Priority Review to Amgen's New Drug Application (NDA) for ivabradine for the treatment of chronic heart failure.
Alkermes announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for aripiprazole lauroxil for the treatment of schizophrenia.
Eli Lilly and Company announced results from its Phase 3 UNCOVER studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis, in which ixekizumab was found to be superior to etanercept.
Baxter announced positive results from its Phase 3 trial of BAX 855, an extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A.
Auxilium announced positive results from a Phase 2a study of Xiaflex (collagenase clostridium histolyticum [CCH]) for the treatment of edematous fibrosclerotic panniculopathy (EEP), also known as cellulite.
Amgen announced results from its Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) receiving hemodialysis.
Actavis announced positive topline results from its Phase 3 studies, RECLAIM-1 and -2, evaluating the use of ceftazidime-avibactam for the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI).
Pfizer announced that it has submitted an NDA to the FDA for palbociclib in combination with letrozole for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for the advanced disease.
The FDA has accepted for review Pfizer's Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), a vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10-25 year olds.
Salix announced top-line results from its Phase 3 TARGET 3 clinical trial evaluating rifaximin 500mg in patients with irritable bowel syndrome with diarrhea (IBS-D), who respond to an initial treatment course with rifaximin 500mg.
The FDA has granted Orphan Drug designation to mocetinostat (Mirati Therapeutics) for diffuse large B-cell lymphoma (DLBCL).
Genentech has submitted a supplemental Biologics License Application (sBLA) to the FDA for Lucentis (ranibizumab) injection for the treatment of diabetic retinopathy.