Bristol-Myers Squibb and Pfizer announced results from the pre-specified secondary analysis of the Phase 3 AMPLIFY-EXT trial with Eliquis (apixaban).
The Food and Drug Administration (FDA) has accepted and granted Priority Review to Ipsen's sNDA for Somatuline Depot (lanreotide acetate) 120mg injection for the treatment of gastoenteropancreatic neuroendocrine tumors (GEP-NETs).
The Food and Drug Admnistration (FDA) has granted Orphan Drug designation for PRM-151 (Promedior) for the treatment of myelofibrosis.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Nuplazid (pimavanserin; Acadia Pharmaceuticals) for the treatment of Parkinson's disease psychosis.
Sanofi and Regeneron announced positive results from four Phase 3 ODYSSEY trials of alirocumab in patients with hypercholesterolemia.
The Food and Drug Administration (FDA) has granted Wockhardt Limited's investigational anti-infectives, WCK 771 and WCK 2349 Qualified Infectious Disease Product (QDIP) status.
Ampio announced an update to the Phase 3 multicenter, double-blind STEP study of Ampion for osteoarthritis (OA) of the knee.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to APD811 (Arena Pharmaceuticals) for the treatment of pulmonary arterial hypertension (PAH).
The Food and Drug Administration (FDA) has granted Fast Track designation to motolimod (VTX-2337; VentiRx) in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy.
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.