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Shire announces resubmission of lifitegrast NDA to FDA for treatment of dry eye disease in adults

Shire announces resubmission of lifitegrast NDA to FDA for treatment of dry eye disease in adults

Shire plc today announced it has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration for its investigational candidate, lifitegrast, for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter (CRL) the company received from the FDA on October 16, 2015. [More]
FDA approves Allergan's sNDA to update label for DALVANCE (dalbavancin) for injection

FDA approves Allergan's sNDA to update label for DALVANCE (dalbavancin) for injection

Allergan plc, a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has approved the company's supplemental new drug application (sNDA) to update the label for DALVANCE (dalbavancin) for injection. [More]
Mylan releases generic version of Felbatol Tablets in U.S.

Mylan releases generic version of Felbatol Tablets in U.S.

Mylan N.V. today announced the U.S. launch of Felbamate Tablets USP, 400 mg and 600 mg, which is the generic version of Meda Pharms' Felbatol Tablets. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product. [More]
Mylan announces U.S. launch of generic Ortho Tri-Cyclen Lo Tablets

Mylan announces U.S. launch of generic Ortho Tri-Cyclen Lo Tablets

Mylan N.V. today announced the U.S. launch of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, which is the generic version of Janssen's Ortho Tri-Cyclen Lo Tablets. [More]
First patient enrolled in Phase 3 efficacy trial of CAM2038 for opioid dependence

First patient enrolled in Phase 3 efficacy trial of CAM2038 for opioid dependence

Braeburn Pharmaceuticals and Camurus announce that the first patient has been randomized in the double blind Phase 3 efficacy trial of CAM2038 in opioid-dependent patients. CAM2038 medications are designed for long-acting weekly and monthly administration. [More]
Amarantus seeks FDA's Rare Pediatric Disease Designation and ODD to treat GCMN with Engineered Skin Substitute

Amarantus seeks FDA's Rare Pediatric Disease Designation and ODD to treat GCMN with Engineered Skin Substitute

Amarantus BioScience Holdings, Inc., a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the US Food and Drug Administration to treat GCMN with Engineered Skin Substitute (ESS). [More]

Mylan announces launch of Linezolid Tablets, 600 mg in U.S.

Mylan N.V. today announced the U.S. launch of Linezolid Tablets, 600 mg, which is the generic version of Pfizer's Zyvox Tablets. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in adults and children for the treatment of certain infections caused by susceptible Gram-positive bacteria. [More]
FDA approves non-alcoholic Docetaxel Injection

FDA approves non-alcoholic Docetaxel Injection

Teikoku Pharma USA, Inc. announced today that the U.S. Food and Drug Administration has approved Docetaxel Injection, Non-Alcohol Formula ("Docetaxel Injection") for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. [More]
Sanofi seeks FDA NDA approval for once-daily fixed-ratio combination of insulin glargine and lixisenatide

Sanofi seeks FDA NDA approval for once-daily fixed-ratio combination of insulin glargine and lixisenatide

Sanofi announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, which if approved would be administered as a single daily injection for the treatment of adults with type 2 diabetes. [More]
EMA CHMP considers AcelRx's ARX-04 for acute pain treatment for centralized review

EMA CHMP considers AcelRx's ARX-04 for acute pain treatment for centralized review

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the intended treatment of acute pain, reported that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has confirmed that a Marketing Authorization Application (MAA) for ARX-04 may be submitted in the European Union (EU) under the Agency's centralized procedure. [More]
CSL submits rIX-FP new drug application to Japan's Pharmaceuticals and Medical Devices Agency

CSL submits rIX-FP new drug application to Japan's Pharmaceuticals and Medical Devices Agency

Global biotherapeutics leader CSL Behring announced today that the company has submitted its new drug application to Japan's Pharmaceuticals and Medical Devices Agency for its investigational fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). [More]
Soligenix reports positive results from SGX942 Phase 2 trial in patients with head and neck cancer

Soligenix reports positive results from SGX942 Phase 2 trial in patients with head and neck cancer

Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive results in its Phase 2 clinical trial, in which SGX942, a first-in-class Innate Defense Regulator (IDR), at a dose of 1.5 mg/kg, successfully reduced the median duration of severe oral mucositis by 50% in all patients and by 67% in patients receiving the most aggressive chemoradiation therapy (CRT) for treatment of their head and neck cancer. [More]
TaiGen releases Taigexyn (nemonoxacin) capsules in Taiwan

TaiGen releases Taigexyn (nemonoxacin) capsules in Taiwan

TaiGen Biotechnology Company, Limited today announced that together with its distribution partner, Holding Distribution, it has launched Taigexyn (nemonoxacin) capsules in Taiwan, the first market where Taigexyn is available. [More]
Kitov Pharmaceuticals' KIT-302 drug candidate meets primary efficacy endpoint in Phase III clinical trial

Kitov Pharmaceuticals' KIT-302 drug candidate meets primary efficacy endpoint in Phase III clinical trial

Kitov Pharmaceuticals, an innovative biopharmaceutical company focused on late-stage drug development, announced today that the Phase III, double-blind, placebo-controlled clinical trial for its leading drug candidate, KIT-302, successfully met the primary efficacy endpoint of the trial protocol as approved by the U.S. Food & Drug Administration (FDA). [More]
Egalet submits NDA for ARYMO ER (morphine sulfate) extended-release tablets

Egalet submits NDA for ARYMO ER (morphine sulfate) extended-release tablets

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, announced the company has submitted a new drug application (NDA) for ARYMO ER (morphine sulfate) extended-release tablets for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. [More]
FDA approves Teligent's sNDA for CEFOTAN (cefotetan) for Injection

FDA approves Teligent's sNDA for CEFOTAN (cefotetan) for Injection

Teligent, Inc., a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company's supplemental new drug application (sNDA) from the U.S. Food and Drug Administration (FDA) for CEFOTAN (cefotetan) for Injection. [More]
FDA grants Fast Track status to Cardiorentis' Ularitide for treatment of ADHF

FDA grants Fast Track status to Cardiorentis' Ularitide for treatment of ADHF

Cardiorentis AG, a privately held biopharmaceutical company, today announced that the U.S. Food and Drug Administration has granted Fast Track status to Ularitide, an investigational therapy for the treatment of acute decompensated heart failure (ADHF). [More]
Sinovac gets approval to begin clinical trials on Sabin Inactivated Polio Vaccine candidate

Sinovac gets approval to begin clinical trials on Sabin Inactivated Polio Vaccine candidate

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, today announced that the Company has obtained approval to begin human clinical trials on its Sabin Inactivated Polio Vaccine (or "sIPV") candidate. [More]
Dompé’s investigational biotech molecule receives orphan drug designation for treatment of neurotrophic keratitis

Dompé’s investigational biotech molecule receives orphan drug designation for treatment of neurotrophic keratitis

The Dompé biopharmaceutical company announced today that the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) has officially designated recombinant human Nerve Growth Factor (rhNGF) - the investigational biotech molecule developed by Dompé based on research by Nobel Laureate Rita Levi Montalcini - as an orphan drug for the treatment of neurotrophic keratitis. [More]
Can-Fite BioPharma reports financial results, provides updates on drug development programs

Can-Fite BioPharma reports financial results, provides updates on drug development programs

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, today reported financial results for the nine months ended September 30, 2015 and updates on its drug development programs. [More]
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