Mitsubishi Tanabe Pharma is seeking manufacturing and marketing approval of TA-7284 (generic name: canagliflozin) in Japan. The company filed a new drug application to the Ministry of Health, Labor and Welfare in Japan for TA-7284 to ...
Tags: Mitsubishi, canagliflozin
TaiGen Biotechnology has submitted New Drug Application (NDA) for the oral formulation of nemonoxacin with the Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration (CFDA). Nemonoxacin is the first ...
Tags: TaiGen Biotechnology, Medicine
Nano Labs Corp. (CTLE) announced the Company has signed a Non-Disclosure Agreement (NDA) with CIVIK of Mexico. The NDA will allow CIVIK to review and test two of Nano Labs' nanotechnologies, the nano insulate coatings and nano diamond ...
Tags: LED Lighting, LED, Lighting
pSivida has announced the availability of the sustained release pharmaceutical product indicated for the treatment of chronic diabetic macular edema (DME), Iluvien, in Germany. Alimera Sciences, pSivida's licensee, has reported the ...
Tags: pSivida Iluvien, Medicine
GreenBlue's Sustainable Packaging Coalition (SPC) held its Spring Conference recently in San Francisco, bringing together professionals from companies, government agencies and other non-profits interested not only in packaging ...
Tags: How2Recycle, Label, Packaging
GlaxoSmithKline (GSK) has submitted a new drug application (NDA) to the US FDA for umeclidinium bromide (UMEC) monotherapy 62.5mcg to treat chronic obstructive pulmonary disease (COPD). The investigational once-daily UMEC, administered ...
Tags: GlaxoSmithKline, FDA Approval, chronic obstructive pulmonary disease
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Allergan's New Drug Application (NDA) for Levadex (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults. In addition ...
Tags: Migraine Therapy, Medicine
The USFDA has accepted Otsuka Pharmaceutical's new drug application (NDA) of tolvaptan for priority review to treat autosomal dominant polycystic kidney disease (ADPKD). The filing was based on Phase III clinical trial results of the drug ...
Tags: Otsuka Tolvaptan NDA, Medicine
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Terumo BCT's automated blood collection system, designed for collecting and storing platelets in Isoplate platelet additive solution (PAS). The solution, which ...
The US FDA has approved Teva Pharmaceutical Industries' new drug application (NDA) for Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets as oral contraceptives. Quartette, designed as next generation of extended ...
Tags: Health, Medicine, oral contraceptives
BioDelivery Sciences International and Arcion Therapeutics have signed a worldwide licensing deal for the development and commercialization of topical clonidine gel (previously ARC4558) to treat painful diabetic neuropathy (PDN) and other ...
Tags: BioDelivery, Arcion Therapeutics, topical clonidine gel development
Boehringer Ingelheim and Eli Lilly and Company have announced the submission of new drug application (NDA) to FDA for an investigational type 2 diabetes mellitus (T2D) treatment, empagliflozin. Empagliflozin belongs to sodium glucose ...
Tags: diabetes therapy, drug application, drug
The US Food and Drug Administration (FDA) has accepted Neos Therapeutics' new drug application (NDA) 505(b)(2) filing for NT0202, an extended release (XR) orally disintegrating tablet (ODT) formulation of Amphetamine Polistirex. The ...
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Nuvo Research's US licensing partner, Mallinckrodt, following the review of Mallinckrodt's New Drug Application (NDA) for diclofenac sodium topical ...
The US Food and Drug Administration (FDA) has accepted to review Iroko Pharmaceuticals New Drug Application (NDA) for lower dose submicron diclofenac, a non-steroidal anti-inflammatory drug (NSAID), with a proposed indication of treatment ...
Tags: FDA, Pharmaceuticals, Medicine