new drug application (NDA)

Uro Pipeline: Phase IIb study begins for intraprostatic localized PCa drugOther pipeline developments include a new company formed to develop OAB treatments, a phase III urothelial cancer study meeting its primary endpoint, the formation of a partnership to study RCC treatment, and more.
2015's glaucoma therapy advancesWhile no new drug shook up the world of glaucoma in 2015, a variety of promising agents made incremental advances toward the market with their true potential as yet unproven. Manufacturers have continued to refine approaches to existing drugs.
Synergy Pharmaceutical's constipation drug garners positive resultsSynergy Pharmaceuticals’ drug for chronic idiopathic constipation (CIC) has garnered very positive results in a phase 3 clinical trial, the company reported this week.
Shire to submit new drug application to FDA for dry eye diseaseShire recently announced its plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lifitegrast for the treatment of dry eye disease in adults in first-quarter 2015.
Shire to submit NDA for dry eye treatmentFollowing a meeting with the FDA last week, Shire has announced that it intends to submit a New Drug Application (NDA) for its dry eye disease treatment, lifitegrast, in the first quarter of 2015, as it completes remaining chemistry and manufacturing work.
FDA seeking more info on Avedro’s corneal cross-linking NDAAvedro Inc. has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its new drug application (NDA) for riboflavin ophthalmic solution/KXL System to treat keratoconus and corneal ectasia after refractive surgery.
Alimera resubmits Iluvien NDA to FDAAlimera Sciences has resubmitted its New Drug Application (NDA) for its fluocinolone acetonide intravitreal implant (Iluvien) to the FDA.
FDA responds to Avedro NDAAvedro Inc. has received a complete response letter from the FDA regarding the new drug application (NDA) for its riboflavin ophthalmic solution/KXL System.