USFDA

Guerbet announced that it has received 510K clearance from the US Food and Drug Agency (FDA) for its OptiOne™ Single-Head Contrast Delivery System, featuring advanced multi-purpose functionality for CT imaging procedures.

RedHill Biopharma Ltd, announced the successful completion of a first-in-man pharmacokinetic (PK) study of BEKINDA™ 12 mg formulation, intended to be administered in the Phase II study for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). RedHill further announced the submission to the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) protocol for the Phase II clinical study with BEKINDA™ 12 mg for IBS-D, planned to be initiated in the coming weeks, subject to final preparations.

KemPharm, Inc. announced that the New Drug Application (NDA) for KP201/APAP, its investigational drug candidate for the short-term management of acute pain, has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA).  In addition, the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 9, 2016.

Aurobindo Pharma Limited announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 500 mg/100 mL (5 mg/mL), and 750 mg/150 mL (5 mg/mL), single-use containers. The product is expected to be launched in Q1 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Levaquin® (Levaquin in 5 % Dextrose) by Janssen Pharmaceuticals, Inc.

Researchers have found that a US Food and Drug Administration (FDA)-approved drug currently used for obese patients and Type-2 diabetics has the potential to be used in the treatment of cocaine dependence.

Pfizer Inc. commends  recommendation by the United States (U.S.) Food and Drug Administration’s (FDA) Arthritis Advisory Committee to approve the investigational biosimilar infliximab (CT-P13) across all eligible indications by a vote of 21 to three.

Spectranetics Corporation announced U.S. Food and Drug Administration (FDA) Premarket Notification 510(k) clearance of the Bridge Occlusion Balloon for temporary vessel occlusion in cardiac lead extraction procedures.

CTI BioPharma Corp. announced that the Company received written communication from the U.S. Food and Drug Administration (FDA) on February 4, 2016, that the FDA has placed a partial clinical hold on the clinical studies being conducted under the Company's Investigational New Drug ("IND") application for pacritinib. This clinical hold impacts part of the clinical work currently being conducted under the IND and will also affect planned clinical trials.

Sangamo BioSciences, Inc., the leader in therapeutic genome editing, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for SB-318, a single treatment strategy intended to provide a life-long therapy for Mucopolysaccharidosis Type I (MPS I).