Sanbio Inc., of Mountain View, Calif., said the FDA has approved its investigational new drug application for the use of SB623, an allogeneic stem cell therapy product, in patients suffering from traumatic brain injuries

KemPharm anticipates submitting a new drug application in the second quarter of 2014...La Jolla Pharmaceutical Co., of San Diego, said it submitted an investigational new drug application for LJPC-501, a peptide agonist of the renin-angiotensin system, for the treatment of patients with Type I and Type II hepatorenal syndrome, a life-threatening form of progressive renal failure in patients with liver cirrhosis or fulminant liver failure

Omeros Corp., of Seattle, said the FDA cleared its investigational new drug application to evaluate OMS824, a selective phosphodiesterase 10 inhibitor, in Huntington's disease...Zensun has filed a new drug application for accelerated market approval in China based on those data, and is planning a Phase III trial in the U.S

Upsher-Smith's new drug application for USL255 was accepted for review by the FDA with an anticipated PDUFA date in December 2013

The company expects to submit a new drug application for the NanoTab System in the third quarter...Perosphere Inc., of Mount Kisco, N.Y., said it received FDA clearance of its investigational new drug application to start clinical testing of PER977 to reverse the anticoagulant activity of unfractionated heparin, low-molecular-weight heparins, fondaparinux and Factor Xa- and IIa inhibitors

The two pivotal studies evaluated the efficacy and safety of LATUDA as monotherapy (PREVAIL 2) or adjunctive therapy (PREVAIL 1) for the treatment of bipolar depression, and supported two supplemental new drug applications that were accepted by the FDA on Oct. 30, 2012

Mirna filed its first investigational new drug application with the FDA for MRX34 earlier this year

The company expects to report top-line results from the current study in late 2013 or early 2014 and to file a new drug application with the FDA in 2014. (See BioWorld Today, March 20, 2013

investigational new drug application in 2014 and begin Phase II studies for psoriasis and atopic dermatitis in the second half of 2014

The company plans to file a new drug application for the NanoTab system in the third quarter. (See BioWorld Today, Nov. 16, 2012...Ltd., of Germantown, Md., said it filed an investigational new drug application (IND) to begin clinical trials of its adipose-derived stem cell product, RNL-JointStem, for the treatment of osteoarthritis

Celltrion Inc., of Incheon, South Korea, said it received investigational new drug application approval from the UK's Medicines and Healthcare products Regulatory Agency to start a Phase I trial of CT-P27, an influenza antibody shown to have efficacy for pandemic and seasonal flu strains, including various subtypes of influenza viruses

R-Tech Ueno, of Tokyo, said it submitted an investigational new drug application to start Phase I/II trials of its recombinant human serum albumin-containing ophthalmic solution, in development for severe dry eye

SK Biopharmaceuticals, of Seoul, South Korea, said the FDA authorized an investigational new drug application for SKL11508 to treat cognitive impairment associated with schizophrenia

Oramed Pharmaceuticals Inc., of Jerusalem, submitted an investigational new drug application (IND) to the FDA for its oral insulin candidate, ORMD-0801 , in response to FDA feedback on its initial IND filing Dec. 31, 2012

The open-label study under an investigational new drug application is designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adults with relapsed/refractory AML

VG Life Sciences Inc., of San Marino, Calif., disclosed positive results from stage 2 of its pre-investigational new drug application Phase I study to test tolerability and toxicity in patients with advanced-stage solid tumors

Erytech Pharma SA, of Lyon, France, said it received clearance of its investigational new drug application for a Phase I trial of Eryasp (L-asparagainase-loaded erythrocytes) in patients 40 years and older with newly diagnosed acute lymphoblastic leukemia

Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., said the FDA accepted its investigational new drug application and announced treatment of the first 15 patients in a trial using Ampion to treat osteoarthritis of the knee...Cleveland BioLabs Inc., of Buffalo, N.Y., and Incuron LLC, a joint venture between the firm and Bioprocess Capital Ventures, said they received a notice of allowance from the FDA for an investigational new drug application for CBL0137

Based on the findings, Trius plans to file a new drug application for tedizolid and to initiate a Phase III study of tedizolid in patients with severe pneumonia during the second half of the year. (See BioWorld Today, Feb. 14, 2013