disclosed Monday afternoon following the market's close that the FDA has asked for additional information from its existing eteplirsen dataset before making a determination about a new drug application (NDA) filing for the drug under Subpart H accelerated approval

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

Merck filed a new drug application with the FDA for a related compound, Suvorexant, in the fall of 2012

Taro Pharmaceutical Industries Ltd., of Hawthorne, N.Y., said the FDA approved its new drug application for Topicort (desoximetasone) Topical Spray 0.25 percent, a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older

IND = Investigational new drug application...NDA = New drug application

In late 2011, Armetheon picked up global rights to tecarfarin – already in late-stage development – in all uses under a structured asset purchase agreement that included assignment of the patents and investigational new drug applications...The goal is to raise a sizable round, achieve the company's development milestones and file a new drug application (NDA) for tecarfarin

The FDA accepted a new drug application from Otsuka Pharmaceutical Co

Proceeds, which will add to the $61.9 million in cash, equivalents and working capital as of Dec. 31, are intended to support a new drug application (NDA) in the U.S., expected midyear, and a marketing authorization application in Europe, expected by year-end, for dalbavancin, a long-acting intravenous lipoglycopeptide, for acute bacterial skin and skin structure infections (ABSSSIs

The company will not submit the new drug application until near the end of 2014, a wait that caused some chagrin among interrogators

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

Merck filed a new drug application with the FDA for a related compound, Suvorexant, in the fall of 2012

Boston Therapeutics Inc., of Manchester, N.H., said it requested an investigational new drug application meeting with the FDA for clinical testing of PAZ320, a nonsystemic chewable drug designed to reduce the elevation of postprandial glucose or postmeal blood sugar in patients with Type II diabetes...StemCells Inc., of Newark, Calif., said it entered an agreement with the California Institute for Regenerative Medicine (CIRM), under which CIRM will provide about $19.3 million to help fund

Synergy submitted an investigational new drug application to the FDA in September 2012

Inc., of Whitehouse Station, N.J., said its new drug application for a tablet formulation of antifungal agent Noxafil (posaconazole) was accepted for review by the FDA

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

From said the company is "probably about 12 months away" from filing an investigational new drug application for that product...The next step for EGP-437 is a second Phase III study to allow filing of a new drug application

Gilead Sciences Inc., of Foster City, Calif., submitted a new drug application (NDA) to the FDA for sofosbuvir, its once-daily oral nucleotide analogue to treat chronic hepatitis C virus (HCV) infection...Sunshine Biopharma Inc., of Montreal, said it completed several investigational new drug application-enabling studies, including one in which the cytotoxic activity of Adva-27a, its lead oncology candidate, was measured in the HMEC (noncancerous human mammary epithielial) cell line

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

Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., said the FDA accepted for filing and granted priority review to its new drug application (NDA) for oral investigational compound riociguat in chronic thromboembolic pulmonary hypertension (CTEPH) that is inoperable or persistent or recurrent CTEPH after pulmonary endarterectomy and pulmonary arterial hypertension