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news.Cangene receives approvable letter from FDA
The drug’s indication is treatment of growth failure in children with growth hormone deficiency and short stature associated with Turner Syndrome. The FDA requested additional support data regarding
The drug’s indication is treatment of growth failure in children with growth hormone deficiency and short stature associated with Turner Syndrome. The FDA requested additional support data regarding
Schering-Plough said that the acquisition would fill a gap in the company's late-stage pipeline by adding five compounds in phase III development and a number of promising projects
Subject to completion, which Japan-based Takeda expects to occur within a few weeks, Paradigm will become a subsidiary of Takeda Europe Holdings, a wholly owned subsidiary of Takeda.
Johnson & Johnson will also have to update the safety information on its erythropoiesis-stimulating agent (ESA) drug Procrit. ESAs are approved to treat anemia in patients with chronic
Patients receiving daclizumab 2mg/kg subcutaneously every two weeks showed a significant reduction in the number of new or enlarged gadolinium-contrast-enhancing lesions (Gd-CELs) at week 24. Daclizumab is a
The FDA published the notice on its website, urging physicians to consider the risk of fracture when treating female patients with type 2 diabetes with pioglitazone-containing products. Three
Teva said that the agency had approved its abbreviated new drug application for moexipril HCl and hydrochlorothiazide tablets, in 7.5mg/12.5mg, 15mg/12.5 mg and 15mg/25mg strengths. The company said
This vaccine is designed to prevent infection by human papillomavirus types 6, 11, 16, 18, 31, 45, and 58, which is expected to provide broader protection than the
US regulators also criticised Takeda for suggesting that the insomnia treatment was safe for use in children. The FDA said that the safety of effectiveness of the drug
Tamiflu, which is indicated for the prevention and treatment of influenza types A and B in patients one year and older, is currently available in a 75mg capsule