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
Janssen Research & Development is seeking US FDA approval for the use of Simeprevir (TMC435) in combination with pegylated interferon and ribavirin to treat genotype 1 chronic hepatitis C in adults. The company submitted a new drug ...
Tags: Health, Medicine, pegylated interferon
The US food and drug administration (FDA) has approved Janssen's Invokana (canagliflozin) for the treatment of adults with type 2 diabetes. Invokana is the oral, once-daily medication available in the US demonstrating improved glycemic ...
How much progress have federal officials made in taking steps to reduce Americans' exposure to arsenic in everyday foods such as rice and apple juice? Not as much as we'd hope to see. While there is an arsenic standard for drinking water, ...
The US Food and Drug Administration (FDA) has approved Biogen Idec's Tecfidera (dimethyl fumarate), a new first-line oral capsule for people suffering from relapsing forms of multiple sclerosis (MS). Tecfidera reduces relapses and ...
Tags: FDA, Biogen capsule, multiple sclerosis
Becton, Dickinson and Company (BD) has announced the FDA approval of first drug, diphenhydramine hydrochloride injection, USP, to be offered in BD Simplist line of prefilled generic injectables. Diphenhydramine Hydrochloride Injection, ...
Tags: FDA, drug, prefilled generic injectables
BioControl Medical has gained the US Food and Drug Administration approval to begin the third and largest phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-center, investigational device exemption (IDE) clinical ...
Tags: BioControl Medical, FDA, Medical
California-based medical device Harbor MedTech has gained FDA marketing approval for its first product, Architect, an advanced collagen matrix for treatment of partial and full thickness skin wounds. Harbor president and founder Jerry ...
The US FDA has accepted Merck's biologics license application (BLA) for an investigational allergy immunotherapy tablet (AIT), Timothy grass pollen (Phleum pratense). The application includes safety and efficacy data of the ...
Tags: FDA, Merck Bla, Allergy Immunotherapy Tablet
The US FDA has cleared Eisai's ACIPHEX Sprinkle (rabeprazole sodium) as 12-week gastroesophageal reflux disease (GERD) therapy for use in children between one to eleven years age. The approval was based on positive data from multicenter, ...
Tags: FDA, Disease Therapy for Children, Medicine
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
Urban Select Capital has entered into a collaboration agreement with Eidam Diagnostics, a Canada-based manufacturer and distributor of medical devices. Under the agreement, Eidam has granted Urban Select a ten-year license to distribute ...
Tags: Eidam Diagnostics, medical devices, medical
Using a low-cost apparatus designed to quickly and accurately measure the properties of handheld laser devices, researchers at the National Institute of Standards and Technology (NIST, an agency of the US Department of Commerce) have tested ...
Tags: handheld laser devices, NIST, laser pointers
Posted by Jack Mans -- Packaging Digest, 3/25/2013 12:22:33 PM The U.S. Department of Energy has approved of the first bionic eye for use in the U.S. The creation of this retinal prosthesis stems, in part, from DOE support for a decade of ...
Tags: FDA, Packaging, Packaging Digest
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