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Tag: nda
ASCO 2015: NDA coming soon as Clovis unveils data in ovarian, NSCLC
2015-05-31 23:38:49| Logistics - Topix.net
Clovis Oncology Inc. took a big step ahead in preparations for filing its new drug application for the experimental non-small cell lung cancer therapy, rociletinib, showcasing data from an ongoing phase II study testing the drug in a group of heavily pre-treated patients, most of whom had developed resistance to current treatments. The company, which plans to use the data as part of a rolling submission to the FDA slated to begin in June, provided the update at the American Society of Clinical Oncology annual meeting.
Xadago (Safinamide) New Drug Application (NDA) Accepted For Filing By The U.S. Food And Drug Administration (FDA)
2015-03-04 02:40:12| drugdiscoveryonline Home Page
Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel central nervous system (CNS) and pain therapies, and its commercial and development partner, Zambon S.p.A., an international pharmaceutical company, announced recently that the New Drug Application (NDA) for Xadago (safinamide) has been accepted for filing by the U.S. Food and Drug Administration (FDA)
Tags: food
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accepted
PTC Therapeutics Begins Rolling NDA Submission To The FDA For Translarna To Treat Duchenne Muscular Dystrophy
2014-12-29 01:59:52| drugdiscoveryonline Home Page
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that it has commenced a rolling submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Translarna™ for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD)
Tags: treat
begins
rolling
submission
Endo Pharmaceuticals and BioDelivery Sciences Announce NDA Submission ...
2014-12-24 16:54:20| Biotech - Topix.net
Endo Pharmaceuticals Inc., a subsidiary of Endo International plc , and BioDelivery Sciences International, Inc. announced today that they have submitted a New Drug Application for Buprenorphine HCl Buccal Film to the U.S. Food and Drug Administration . Buprenorphine HCl Buccal Film is under development for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Tags: sciences
submission
announce
pharmaceuticals
FDA Accepts Mercks NDA for Fixed-Dose Combination of Raltegravir with Lamivudine
2014-06-24 14:30:35| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. If Approved, Fixed-Dose Combination Would Be Used with Other Antiretroviral Agents for the Treatment of HIV-1 in Adults, Adolescents and Certain Pediatric Patients Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for a fixed-dose combination (FDC) of raltegravir with lamivudine for the treatment of HIV-1 infection (MK-0518B) has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Language: English read more
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combination
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