USFDA

- Read more about Durvalumab granted Breakthrough Therapy designation by US FDA
AstraZeneca and MedImmune, its global biologics research and development arm, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen.
- Read more about FDA approves medtronic deep Brain Stimulation for people with Parkinson's Disease with recent onset of motor complications
Medtronic plc announced U.S. Food and Drug Administration (FDA) approval of Medtronic Deep Brain Stimulation (DBS) Therapy for use in people with Parkinson's disease of at least four years duration and with recent onset of motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication. In 2002, the FDA initially approved Medtronic DBS Therapy for use in patients with advanced Parkinson's disease. Medtronic DBS has demonstrated improvement in motor complications, quality of life, activities of daily living and reduction in medication usage in individuals with Parkinson's disease.
- Read more about Biota receives FDA fast track designation for its antiviral BTA585
Biota Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its antiviral compound, BTA585, for the treatment of respiratory syncytial virus (RSV) infections in infants, young children and adults.
- Read more about Clovis Oncology Rociletinib NDA scheduled for presentation at upcoming FDA ODAC
Clovis Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12, 2016.
- Read more about Optovue’s AngioVue imaging system receives FDA clearance
Optovue announced FDA clearance and immediate U.S. commercial availability of the AngioVue™ Imaging System, a groundbreaking technology that provides a non-invasive way to visualize abnormal blood vessels in the retina to help physicians determine an appropriate course of treatment.
- Read more about Guerbet receives FDA 510k clearance for the OptiOne™ single-head contrast delivery system
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.
- Read more about RedHill Biopharma announces successful PK study With BEKINDA™ 12 mg and submission to FDA of IBS-D Phase II study Protocol
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.
- Read more about Cellceutix will submit SPA to FDA for phase 3 for treatment of ABSSSI
Cellceutix Corporation will be submitting a Special Protocol Assessment (SPA) request for phase 3 clinical research of its novel single-dose antibiotic, Brilacidin, for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria. The Company anticipates submission of the SPA request to the U.S. Food and Drug Administration (FDA) within two weeks.
- Read more about FDA Grants Priority Review to KemPharm for KP201/APAP NDA
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.
- Read more about Aurobindo Pharma receives USFDA approval for Levofloxacin in Dextrose Injection
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.