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This opinion paves the way for Plandaí to immediately commence sales efforts in the United States. The Federal Food, Drug and Cosmetic Act requires that the US FDA

Pegsiticase has shown the ability to efficiently reduce plasma uric acid levels in gout patients in successful U.S. Phase 1 clinical tests. The exclusive license enables Selecta to

The trial is designed to assess the safety and efficacy of Pyridorin in slowing disease progression in patients with diabetic nephropathy. NephroGenex CEO Pierre Legault said with the

Pharma Technology Focus’ digital magazine brings together the latest news from the pharmaceutical industry, as well as offering expert views and analysis from industry insiders to ensure the

Being developed for the treatment of several cancer indications including patients with recurrent glioblastoma, DNX-2401 is claimed to be the most potent and effective oncolytic virus delivered to

Prestalia, which is the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate, is indicated for the treatment of hypertension in the U.S. Perindopril is a

The investigational, all-oral, interferon-free medicine is primarily indicated for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. The three direct-acting antiviral

Soliris (eculizumab) is currently approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It is not approved in any country

Critical Outcome Technologies president and CEO Dr Wayne Danter said that receiving the Orphan Drug Designation for COTI-2 speaks to the need for new treatment options for patients