Nicox S.A. has resubmitted AC-170, its conjunctivitis associated itching drug candidate, for US FDA review after its API supplier resolved the problems that saw the agency reject the New Drug Application (NDA) last year.
While the demand for new diabetes therapies grows, the development of endocrine drugs is riskier than all other drug development, according to a study conducted by the Tufts Center for the Study of Drug Development.
The US FDA has accepted for review Opko Health’s New Drug Application for a potential treatment for chronic kidney disease (CKD) and vitamin D insufficiency that uses Catalent’s proprietary softgel technology as its delivery platform.
California-based Relypsa has entered into a seven-year commercial manufacturing and supply agreement with DSM Fine Chemicals for the API for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. Financial details...
The US FDA on Monday announced in a draft guidance that it’s revising its historical interpretation of the 5-year NCE exclusivity provisions to further incentivize the development of certain fixed-combination products.
The parallel QbD (Quality by Design) application review program by the US FDA and EMA is slowly revealing the differences between the two agencies but will never result in identical assessments or outcomes, experts said.