AMAG Pharmaceuticals Inc., of Lexington, Mass., said the FDA accepted for review its supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for intravenous use

The stock (NASDAQ:SPPI), which closed at $11.49 Monday, is payable on an FDA acceptance for review of the belinostat new drug application, along with a $10 million cash milestone

The stock (NASDAQ:SPPI), which closed at $11.49 Monday, is payable on an FDA acceptance for review of the belinostat new drug application, along with a $10 million cash milestone

plc, of Dublin, Ireland., submitted a supplemental new drug application to the FDA for Vascepa (icosapent ethyl) to treat high triglycerides with mixed dyslipidemia as an adjunct to diet...A new drug application and marketing authorization are planned for the third quarter

The stock (NASDAQ:SPPI), which closed at $11.54 Tuesday, up 5 cents, is payable on an FDA acceptance for review of the belinostat new drug application, along with a $10 million cash milestone

Tarsa had expected to submit a new drug application (NDA) this year for Ostora, licensed from Unigene Laboratories Inc., with an initial indication targeting women with mild to moderate osteoporosis who cannot tolerate existing therapies. (See BioWorld Today, March 19, 2012, and March 4, 2013.) If the FDA goes along with the committees' vote, the Philadelphia-based drugmaker may have to rethink its development plans for Ostora, which generated positive Phase III data, demonstrating significant

The FDA said Mallinckrodt had successfully completed its pharmacokinetic study comparing Pennsaid 2 percent to original Pennsaid 1.5 percent, but that similar pharmacokinetic studies submitted with the new drug application were not acceptable because reserve samples were not retained at the clinical site

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA issued a second complete response letter regarding a supplemental new drug application for Xarelto (rivaroxaban) for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome

The company plans to submit those data as part of a supplemental new drug application in the second half of this year

Merz has a new drug application under FDA review for naftifine hydrochloride gel 2 percent and expects a decision by FDA on the application this summer

Iroko Pharmaceuticals LLC, of Philadelphia, said the FDA accepted for review the new drug application (NDA) for lower-dose submicron diclofenac, a nonsteroidal anti-inflammatory drug, with a proposed indication of treatment of mild to moderate acute pain in adults

new drug application is filed

filed an abbreviated new drug application (ANDA) with the FDA seeking approval to market Testosterone gel 10 mg/0.5g

That drug, partnered with Emisphere Technologies Inc., showed small numerical improvements in reduction of fractures in Phase III testing in 2011, but data fell short of statistical significance, prompting the Swiss big pharma firm to opt out of further development. (See BioWorld Today, Nov. 15, 2011.) Philadelphia-based Tarsa, which is anticipating a new drug application this year, has said it likely will aim Ostora initially at patients with mild to moderate disease who cannot tolerate

In the first IPO window, 26 percent of companies had Phase III compounds and another 24 percent had filed a new drug application (NDA) or had a drug already on the market

Ceptaris Therapeutics Inc., of Malvern, Pa., said it resubmitted the new drug application for its gel formulation of mechlorethamine hydrochloride to the FDA, seeking approval for the treatment of early stage (Stages I-IIa) mycosis fungoides...QRxPharma Ltd., of Sydney, Australia, said it resubmitted its MOXDUO (oxycodone/morphine) new drug application, including the FDA-requested respiratory safety results of Study 022

for the FDA's acceptance of the new drug application for antisense drug Kynamro (mipomersen) and approximately $30 million in net proceeds from its issuance of 2 percent notes

Genervon is putting together an investigational new drug application and aims to reach out to ALS patient groups to help with trial enrollment

Titan Pharmaceuticals Inc., of South San Francisco, said the FDA's Psychopharmacologic Drugs Advisory Committee is scheduled to review the firm's new drug application (NDA) for Probuphine for the maintenance treatment of adults with opioid dependence on March 21...Zogenix Inc., of San Diego, said the FDA informed the firm that it is unlikely to receive an action letter for its new drug application for Zohydro ER (hydrocodone bitartrate extended-release capsules) by the PDUFA goal of March 1